Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2050010

FEI Number

2050010

Entity Name

BECKMAN COULTER, INC.

City/State/Country

CARLSBAD, CA, US

Establishment Address

2470 Faraday Ave, CARLSBAD, CA 92010, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

BECKMAN COULTER, INC. (Owner Number: 2050012)

Owner / Operator Contact Address

250 S. Kraemer Blvd, --, Brea, CA 92821, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

465440 Vigil Serology Control Level C 445850 Triglycerides Reagent (TG 2 x 300) 445915 Synchron CX CRP Calibrator 465131 C-Reactive Protein Reagent (CRP 2 x 200) 657365 SYNCHRON Control Multilevel Comprehensive Chemistry Control Serum 475100 Microalbumin Reagent (MA 2 x 100) 476851 Lipase Reagent (LIP 2 x60) 467942 Transferrin Reagent (TRFN 2 x 150) SYNCHRON Transferrin 445990 Cannabinoid 100 ng Reagent (THC 1 x 150) 475006 Opiate 2000 ng Reagent (OP2 1 x 250) 446440 IMMAGE Immunochemistry Systems KAP Kappa Light Chain Reagent 446470 IMMAGE Immunochemistry Systems LAM Lambda Light Chain Reagent 378194 Salicylate Reagent (SALY 2 x 45) Synchron Salicylate test system 471080 SYNCHRON Systems Drug Calibrator 3 Plus 447630 IMMAGE Immunochemistry Systems TRF Transferrin Reagent 469630 SYNCHRON Systems Drug Calibrator 2 A15625 HDL Cholesterol Reagent HDL 2 x 200 B23634 UniCel DxC SYNCHRON Systems HDL Calibrator SYNCHRON Systems SYNCHRON PROTEIN CALIBRATOR LEVELS 1 and 2 Calcium Electrode Glucose Oxygen Sensor NA+ Electrode BUN Electrode Chloride Electrode Potassium Electrode CO2 Electrode 475089 SYNCHRON Systems MA Calibrator 469283 APO CAL Apolipoprotein Calibrator 969650 Pancreatic Amylase Reagent (PAM 2 x 60) 465365 Immunochemistry Systems LPA CAL Lipoprotein(a) Calibrator 447450 IMMAGE Immunochemistry Systems LPAX Lipoprotein (a) Reagent 474947 Alcohol Reagent (ETOH 2 x 150) 474994 SYNCHRON Systems ETOH Calibrator 465980 Vigil Lipid Control Level 2 469905 Vigil Lipid Control Level 1 465981 Vigil Lipid Control Level 3 465982 Vigil Lipid Control Level 4 OSR6119 GLUTAMYLTRANSFERASE (GGT) OSR6219 GAMMA-GLUTAMYLTRANSFERASE (GGT) A09426 Phosphorus Reagent (PHS 2 x300) LDL & VLDL PRECIPITATION, CHOLESTEROL VIA ESTERASE -OXIDASE, HDL 469112 Carbamazepine Reagent (CAR 2 x 100) 469785 Phenobarbital Reagent (PHE 2 x 100) 469188 Phenytoin Reagent (PHY 2 x 100) 467983 Tobramycin Reagent (TOB 2 x 100) 469600 SYNCHRON Systems Drug Calibrator 1 469137 Gentamicin Reagent (GEN 2 x 100) 469126 Theophylline Reagent (THE 2 x 100) 378045 SYNCHRON Systems Vancomycin Calibrator 474824 Vancomycin Reagent (VANC 2 x 100) Total Immunoglobulin E (IgE) - C22529 445360 Magnesium Reagent (MG 2 x 100) SYNCHRON Magnesium 469965 SYNCHRON Systems CAL 5 Plus 447720 IMMAGE Immunochemistry Systems CER Ceruloplasmin Reagent 447480 IMMAGE Immunochemistry Systems DNB Antideoxyribonuclease-B Reagent 447780 IMMAGE Immunochemistry Systems AAG Alpha-1-Acid Glycoprotein Reagent B24985 Glucose Reagent GLUH 2 x 300 441470 Immunochemistry Systems UCAL Urine Protein Calibrator 445824 Cannabinoid 20 ng Reagent (THC2 1 x 150) 464390 SYNCHRON Systems 20 ng/mL THC Urine Calibrator 467858 SYNCHRON Systems Albumin Reagent SYNCHRON Systems Glucose Reagent (Glucose Oxidase) SYNCHRON Systems CO2 Alkaline Buffer Synchron Systems Total Protein Reagent SYNCHRON Systems Phosphorus Reagent SYNCHRON Systems CO2 Acid Reagent SYNCHRON Systems Urea Nitrogen (BUN) Reagent NA+ Electrode UniCel DxC 600 PRO, Recon UniCel DxC 600, Recon UniCel DxC 800 PRO, Recon UniCel DxC 800, Recon Calcium Electrode CO2 Electrode Chloride Electrode Potassium Electrode PerFix NC Kit (Fixative Reagent) 447420 IMMAGE Immunochemistry Systems BUF 4 Buffer 4 A28945 SYNCHRON Systems ISE Electrolyte Buffer 657133 Cartridge Chemistry Wash Solution (CCWA 2 x 300) UniCel DxI Wash Buffer II OnBoard Dilution Kit (A79784 MN MFG) 445865 SYNCHRON Systems Wash Concentrate II 472137 SYNCHRON and AU Systems Hemolyzing Reagent 447650 IMMAGE Immunochemistry Systems BUF 1 Buffer 1 Iris® System Cleanser Pack (800-3203) 447050 IMMAGE Immunochemistry Systems BUF 3 Buffer 3 447040 IMMAGE Immunochemistry Systems BUF 2 Buffer 2 598190 598190 Trace-Klean Ready to Use Cleaning Solution 447660 IMMAGE Immunochemistry Systems DIL 2 Diluent 2 589784 Trace-Klean Concentrated Cleaning Solution A28937 SYNCHRON Systems ISE Electrolyte Reference A88469 HbDIL DxC iChem® VELOCITY Wash Solution Case of 2 x 7L (800-7217) Iris® Diluent Pack (800-3202) 467826 Sample Diluent 1 DIL1 447640 IMMAGE Immunochemistry Systems DIL 1 Diluent 1 469110 Synchron Systems NO FOAM 447060 IMMAGE Immunochemistry Systems Wash Solution 445967 SYNCHRON CX Systems Antifoam 442831 PVT 2, 472055 PVT 5, 442830 PVT 3 DTCS Quick Start Kit DNA Size Standard Kit - 400 DNA Size Standard Kit - 600 Separation Buffer SEPARATION GEL-LPA I CEQ Sample Loading Solution Separation Gel LPAI DNA Sequencing Separation Buffer Sample Loading Solution (SLS) DNA Size Standard Kit - 80 GenomeLab GeXP Start Kit iQ Body Fluids Lysing Reagent (800-3213) iQ Lamina 2 x 7L (800-3236) iQ Body Fluids Conical Tubes (800-3215) 66039 Cleaning Solution 664090 CLENZ Solution Access Wash Buffer II ( P/N: A16972 KY and DE MFG) Access Substrate (P/N: 81906 MN MFG) Flow Check Pro Fluorospheres UniCel DxI Access Wash Buffer II (P/N: A16973 KY and DE MFG) Access Sample Diluent A (P/N: 81908 MN MFG) FLOW-CHECK Access Sample Diluent A (Onboard Reagent Kit) (P/N: A79783 MN MFG) LumiPhos PRO Substrate (P/N: B96000 MN MFG) DxFLEX Daily QC Fluorospheres ODR2000 5L WASH SOLUTION OSR62166 LIH OSR0001 WASH SOLUTION 657197 Synchron AUTO-GLOSS CTS A18298 Benzodiazepine Reagent (BNZG 1 x 250) A71607 Amylase Reagent (AMY7 2 x 200) SYNCHRON G7 Amylase Reagent IRISpec CA/CB/CC Urine Chemistry Controls (800-7211) iChemVELOCITY CalChek Kit (800-7703) 445860 Microprotein Reagent (M-TP 2 x 50) SYNCHRON Micro Total Protein 969706 Direct LDL Cholesterol Reagent (LDLD 2 x 100) A60298 Enzymatic Creatinine Reagent (CR-E 2 x 300) 439770 Ammonia Reagent (AMM 2 x 25) Synchron AMM reagent and calibrators Part numbers include, but are not limited to A87905 Hemoglobin A1c Reagent (HbA1c- 400) 467845 Aspartate Aminotransferase Reagent (AST- 2 x 300) 467849 Aspartate Aminotransferase Reagent (AST- 2 x 100) 442635 Creatine Kinase Reagent (CK 2 x 200) 442665 Aspartate Aminotransferase Reagent (AST 2 x 200) 467830 Creatine Kinase Reagent (N-Acetyl-L-cysteine) (CK- 2 x 200) 476836 Creatine Kinase Reagent (CK 2 x 400) 476831 Aspartate Aminotransferase Reagent (AST 2 x 400) 475027 Propoxyphene Reagent (PROX 1 x 250) 465300 Immunochemistry Systems Level 2 Urine Protein Control 465290 Immunochemistry Systems Level 1 Urine Protein Control OSR6165 HAPTOGLOBIN 988413 Haptoglobin Reagent (HPT 2 x 100) QUANTIPLATE OR ENDOPLATE TM HA 476856 Direct Bilirubin Reagent (DBIL 2 x 300) 465915 SYNCHRON SYSTEMS BILIRUBIN CALIBRATOR 439715 Direct Bilirubin Reagent (DBIL 2 x 200) 442600 SYNCHRON Systems SYNCHRON Multi Calibrator 447690 IMMAGE Immunochemistry Systems MA Microalbumin Reagent A38656 IMMAGE Immunochemistry Systems CCRP High Sensitivity Cardiac CRP Reagent 469975 CAL 5 PLUS Calibrator 5 Plus Immage CAL 5 Plus Part numbers include, but are not limited to Immage CCRP reagent 446410 IMMAGE Immunochemistry Systems APA Apolipoprotein A1 Reagent 447730 IMMAGE Immunochemistry Systems APB Apolipoprotein B Reagent 467995 Valproic Acid Reagent (VPA 2 x 100) 467905 Apolipoprotein B Reagent (ApoB 2 x 100) 467900 Apolipoprotein A Reagent (ApoA 2 x 100) 469170 SYNCHRON Systems APO Calibrator 475081 SYNCHRON Systems PAB Calibrator 472472 Vigil TDM Control level 3 472467 Vigil TDM Control level 2 472461 Vigil TDM Control level 1 ENZYMATIC BILIRUBIN REAGENT 969620 C-Reactive Protein Reagent (C-RP 2 x 200) 667710 Ultimate -D Bilirubin Control Level 1 667730 Ultimate -D Bilirubin Control Level 3 667720 Ultimate -D Bilirubin Control Level 2 667740 Ultimate -D Bilirubin Control Level 4 447700 IMMAGE Immunochemistry Systems TRU Urine Transferrin Reagent 447710 IMMAGE Immunochemistry Systems A1M Alpha-1-Microglobulin Reagent 683802 Enzymatic Bilirubin Reagent 447280 IMMAGE Immunochemistry Systems CRP C-Reactive Protein Reagent 475106 Prealbumin Reagent (PAB 2 x 100) 442765 Albumin Reagent (ALB 2 x 300) 442820 Urea Reagent (UREA 2 x 300) 447740 IMMAGE Immunochemistry Systems AAT Alpha-1-Antitrypsin Reagent 447440 IMMAGE Immunochemistry Systems PAB Prealbumin Reagent 447020 IMMAGE Immunochemistry Systems IGU Urine Immunoglobulin G Reagent 475003 Cocaine Metabolite Reagent (COCM 1 x 250) 445811 SYNCHRON Systems 100 ng/mL THC Urine Calibrator 445814 SYNCHRON Systems 200 ng/mL THC Urine Calibrator 465912 SYNCHRON Systems 75 ng/mL THC Urine Control 465939 SYNCHRON Systems 125 ng/mL THC Urine Control 475030 Cannabinoid 50 ng Reagent (THC5 1 x 250) 445809 SYNCHRON Systems 50 ng/mL THC Urine Calibrator 465914 SYNCHRON Systems 20 ng/mL THC Urine Control 465990 SYNCHRON SYSTEMS Ammonia/Alcohol Control LEVEL 1 465996 SYNCHRON SYSTEMS Ammonia/Alcohol Control LEVEL 3 465993 SYNCHRON SYSTEMS Ammonia/Alcohol Control LEVEL 2 475009 Phencyclidine Reagent (PCP 1 x 250) 450125 Vigil Protein Control Level 2 450130 Vigil Protein Control Level 3 450120 Vigil Protein Control Level 1 474630 IMMAGE Immunochemistry Systems CRPH High Sensitivity CRP Reagent Enzymatic Creatinine Reagent (CR-E 2 x 200) 465910, Synchron CX Calibrator 3 465909, Synchron CX Calibrator 2 465908, Synchron CX Calibrator 1 650182 Digoxin Reagent (DIGN 2 x 100) 474620 IMMAGE Immunochemistry Systems IGE Total Immunoglobulin E Reagent BECKMAN ENZYMATIC ALT REAGENT KIT COULTER U-V ZYME SGPT REAGENT 442620 Alanine Aminotransferase Reagent (ALT 2 x 200) 476826 Alanine Aminotransferase Reagent (ALT 2 x 400) 467848 Alanine Aminotransferase Reagent (ALT- 2 x 100) 467840 Alanine Aminotransferase Reagent (ALT- 2 x 300) 447610 IMMAGE Immunochemistry Systems IGM Immunoglobulin M Reagent 446460 IMMAGE Immunochemistry Systems IGA Immunoglobulin A Reagent 446400 IMMAGE Immunochemistry Systems IGG Immunoglobulin G Reagent OSR6616 CHOLESTEROL 467825 Cholesterol Reagent (CHOL 2 x 300) SYNCHRON Cholesterol OSR6516 CHOLESTEROL OSR6216 CHOLESTEROL OSR6116 CHOLESTEROL BECKMAN ENZYMATIC CH 445803 SYNCHRON Systems DAT Negative Urine Calibrator 475012 Barbiturates Reagent (BARB 1 x 250) 445930 SYNCHRON Systems Microprotein Calibrator 465970 Total Iron Binding Capacity Reagent (IBCT 2 x 100) 465971 Total Iron Binding Capacity Reagent (IBCT 2 x 100) 442772 SYNCHRON Systems FE/IBCT Calibrator Kit 467910 Iron Reagent (FE 2 x 200) 465976 SYNCHRON Systems Total Iron Binding Capacity (IBCT) Column Kit 447460 IMMAGE Immunochemistry Systems IGALC Low Concentration ImmunoglobuIin A A40920 Creatinine Reagent (CR-S 2 x 300) SYNCHRON Creatinine Synchron Glucose 650218 SYNCHRON Systems Lipid Calibrator Levels 1 & 2 B36415 Hemoglobin A1c Reagent (HbA1c3 250) 450162 Vigil Serology Control Level 1 450163 Vigil Serology Control Level 2 450164 Vigil Serology Control Level 3 447470 IMMAGE Immunochemistry Systems IGMLC Low Concentration ImmunoglobuIin M 474020 IMMAGE Immunochemistry Systems CSF-CAL Cerebrospinal Fluid Protein Calibrator 467925 Immunoglobulin G Reagent (Ig-G 2 x 150) 467920 Immunoglobulin A Reagent (Ig-A 2 x 150) 467930 Immunoglobulin M Reagent (Ig-M 2 x 150) Hemoccult ICT Immunochemical Fecal Occult Blood Test (PN 395067) Hemoccult ICT Immunochemical Fecal Occult Blood Test (PN 395261) Hemoccult ICT Immunochemical Fecal Occult Blood Test (PN 395066) Hemoccult ICT Immunochemical Fecal Occult Blood Test Controls (PN 395068) Hemoccult ICT Immunochemical Fecal Occult Blood Test Collection Cards (PN 395065) Hemoccult SENSA Single Slides (PN A96636) 442785 Uric Acid Reagent (URIC 2 x 300) SYNCHRON Uric acid PerFix NC Kit (Lysing Reagent) IRIS BODY FLUIDS LYSING REAGENT AQUIOS Lysing Reagent Kit Fixative Solution (10X) OptiLyse C : Lysing Solution Lysing Solution (10X) IntraPrep Reagent 2: Permeabilization IOTest 3 Fixative VersaLyse : Lysing Solution IOTest 3 Lyse DxH 500 Series Lyse (PN B36846) Whole Blood Lysing Reagent COULTER Rinsol Cleaning Agent DxH Cell Lyse 1L & 5L AcT 5diff Fix DxH Retic Pack IMMUNOPREP REAGENT DxH diff Pack AcT 5diff Hgb Lyse COULTER DxH Cell Lyse DxH ECO Cell Lyse (5L) AcT 5diff WBC Lyse Access Red Blood Cell Folate Lysing Agent DxH ECO Cell Lyse (1L) Access Red Blood Cell Folate Lysing Agent (P/N: A14206 CA MFG) 378020 High Sensitivity Cardiac C-Reactive Protein Reagent (CRPH 2 x 200) Part numbers include, but are not limited to Synchron CRPH reagent AQUIOS Sodium Hypochlorite Solution AQUIOS Cleaning Agent (PN B25698) DxH 500 Series Cleaner (PN 36868) DxH Cleaner AcT 5diff Rinse Flow Clean (PN A64669) CLENZ AQUIOS Cleaning Agent (PN C48097) Flow Clean (PN C48093) 447760 IMMAGE Immunochemistry Systems PFB Properdin Factor B Reagent 447070 IMMAGE Immunochemistry Systems RF Rheumatoid Factor Reagent 475018 SYNCHRON Systems Methadone Reagent

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JJY	Multi-Analyte Controls, All Kinds (Assayed)	Clinical Chemistry	Class 1	862.1660	2013-02-01
CDT	Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides	Clinical Chemistry	Class 1	862.1705	2013-02-01
DCK	C-Reactive Protein, Antigen, Antiserum, And Control	Immunology	Class 2	866.5270	2013-02-01
JJY	Multi-Analyte Controls, All Kinds (Assayed)	Clinical Chemistry	Class 1	862.1660	2013-02-04
DCF	Albumin, Antigen, Antiserum, Control	Immunology	Class 2	866.5040	2010-05-10
CHI	Lipase-Esterase, Enzymatic, Photometric, Lipase	Clinical Chemistry	Class 1	862.1465	1996-04-29
DDG	Transferrin, Antigen, Antiserum, Control	Immunology	Class 2	866.5880	2011-12-30
DLJ	Calibrators, Drug Specific	Clinical Toxicology	Class 2	862.3200	2013-02-01
LDJ	Enzyme Immunoassay, Cannabinoids	Clinical Toxicology	Class 2	862.3870	2013-02-01
DJG	Enzyme Immunoassay, Opiates	Clinical Toxicology	Class 2	862.3650	2013-02-01
DFH	Kappa, Antigen, Antiserum, Control	Immunology	Class 2	866.5550	2012-12-18
DEH	Lambda, Antigen, Antiserum, Control	Immunology	Class 2	866.5550	2012-12-18
JIX	Calibrator, Multi-Analyte Mixture	Clinical Chemistry	Class 2	862.1150	2012-12-18
DKJ	Colorimetry, Salicylate	Clinical Toxicology	Class 2	862.3830	2012-09-06
DKB	Calibrators, Drug Mixture	Clinical Toxicology	Class 2	862.3200	2013-02-06
DDG	Transferrin, Antigen, Antiserum, Control	Immunology	Class 2	866.5880	2013-02-01
JIX	Calibrator, Multi-Analyte Mixture	Clinical Chemistry	Class 2	862.1150	2013-02-01
DLJ	Calibrators, Drug Specific	Clinical Toxicology	Class 2	862.3200	2013-02-01
LBS	Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl	Clinical Chemistry	Class 1	862.1475	2015-02-27
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2015-02-27
JJE	Analyzer, Chemistry (Photometric, Discrete), For Clinical Use	Clinical Chemistry	Class 1	862.2160	2010-03-18
CEO	Phosphomolybdate (Colorimetric), Inorganic Phosphorus	Clinical Chemistry	Class 1	862.1580	2010-03-18
CDS	Electrode, Ion Specific, Urea Nitrogen	Clinical Chemistry	Class 2	862.1770	2010-03-18
CGZ	Electrode, Ion-Specific, Chloride	Clinical Chemistry	Class 2	862.1170	2010-03-18
JIX	Calibrator, Multi-Analyte Mixture	Clinical Chemistry	Class 2	862.1150	2010-03-18
CIX	Bromcresol Green Dye-Binding, Albumin	Clinical Chemistry	Class 2	862.1035	2010-03-18
CGX	Alkaline Picrate, Colorimetry, Creatinine	Clinical Chemistry	Class 2	862.1225	2010-03-18
CGA	Glucose Oxidase, Glucose	Clinical Chemistry	Class 2	862.1345	2010-03-18
JFL	Ph Rate Measurement, Carbon-Dioxide	Clinical Chemistry	Class 2	862.1160	2010-03-18
CEM	Electrode, Ion Specific, Potassium	Clinical Chemistry	Class 2	862.1600	2010-03-18
JGS	Electrode, Ion Specific, Sodium	Clinical Chemistry	Class 2	862.1665	2010-03-18
CEK	Biuret (Colorimetric), Total Protein	Clinical Chemistry	Class 2	862.1635	2010-03-18
JFP	Electrode, Ion Specific, Calcium	Clinical Chemistry	Class 2	862.1145	2010-03-18
JIS	Calibrator, Primary	Clinical Chemistry	Class 2	862.1150	2013-02-04
JIX	Calibrator, Multi-Analyte Mixture	Clinical Chemistry	Class 2	862.1150	2013-02-04
JFJ	Catalytic Methods, Amylase	Clinical Chemistry	Class 2	862.1070	2013-02-01
DFC	Lipoprotein, Low-Density, Antigen, Antiserum, Control	Immunology	Class 2	866.5600	2011-08-01
JIS	Calibrator, Primary	Clinical Chemistry	Class 2	862.1150	2011-08-01
DNN	Calibrators, Ethyl Alcohol	Clinical Toxicology	Class 2	862.3200	2013-02-01
DMT	Enzymatic Method, Alcohol Dehydrogenase, Ultraviolet	Clinical Toxicology	Class 2	862.3040	2013-02-01
JJY	Multi-Analyte Controls, All Kinds (Assayed)	Clinical Chemistry	Class 1	862.1660	2013-02-01
JQB	Kinetic Method, Gamma-Glutamyl Transpeptidase	Clinical Chemistry	Class 1	862.1360	2004-07-29
CEO	Phosphomolybdate (Colorimetric), Inorganic Phosphorus	Clinical Chemistry	Class 1	862.1580	2013-02-01
LBS	Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl	Clinical Chemistry	Class 1	862.1475	2004-03-29
LFN	Nephelometric Inhibition Immunoassay, Phenobarbital	Clinical Toxicology	Class 2	862.3660	2009-12-22
LCD	Enzyme Immunoassay, Gentamicin	Clinical Toxicology	Class 2	862.3450	2009-12-22
LCQ	Fluorescent Immunoassay Gentamicin	Clinical Toxicology	Class 2	862.3450	2009-12-22
KLS	Enzyme Immunoassay, Theophylline	Clinical Toxicology	Class 2	862.3880	2009-12-22
LCR	Fluorescent Immunoassay, Tobramycin	Clinical Toxicology	Class 2	862.3900	2009-12-22
DKB	Calibrators, Drug Mixture	Clinical Toxicology	Class 2	862.3200	2009-12-22
DIP	Enzyme Immunoassay, Diphenylhydantoin	Clinical Toxicology	Class 2	862.3350	2009-12-22
KLT	Enzyme Immunoassay, Carbamazepine	Clinical Toxicology	Class 2	862.3645	2009-12-22
DLJ	Calibrators, Drug Specific	Clinical Toxicology	Class 2	862.3200	2010-09-01
LEH	Radioimmunoassay, Vancomycin	Clinical Toxicology	Class 2	862.3950	2010-09-01
DGC	Ige, Antigen, Antiserum, Control	Immunology	Class 2	866.5510	2022-03-29
JGJ	Photometric Method, Magnesium	Clinical Chemistry	Class 1	862.1495	2011-12-30
JIX	Calibrator, Multi-Analyte Mixture	Clinical Chemistry	Class 2	862.1150	2013-02-04
DDB	Ceruloplasmin, Antigen, Antiserum, Control	Immunology	Class 2	866.5210	2013-02-01
GTR	Antideoxyribonuclease, Streptococcus Spp.	Microbiology	Class 1	866.3720	1983-09-27
LKL	Alpha-1-Acid-Glycoprotein, Antigen, Antiserum, Control	Immunology	Class 1	866.5420	2023-12-18
JIX	Calibrator, Multi-Analyte Mixture	Clinical Chemistry	Class 2	862.1150	2023-12-18
CFR	Hexokinase, Glucose	Clinical Chemistry	Class 2	862.1345	2015-01-09
JIX	Calibrator, Multi-Analyte Mixture	Clinical Chemistry	Class 2	862.1150	2013-02-04
DKB	Calibrators, Drug Mixture	Clinical Toxicology	Class 2	862.3200	2009-12-31
LDJ	Enzyme Immunoassay, Cannabinoids	Clinical Toxicology	Class 2	862.3870	2009-12-31
JJE	Analyzer, Chemistry (Photometric, Discrete), For Clinical Use	Clinical Chemistry	Class 1	862.2160	2012-01-05
DLZ	Enzyme Immunoassay, Phenobarbital	Clinical Toxicology	Class 2	862.3660	2012-01-05
CEM	Electrode, Ion Specific, Potassium	Clinical Chemistry	Class 2	862.1600	2012-01-05
CJW	Bromcresol Purple Dye-Binding, Albumin	Clinical Chemistry	Class 2	862.1035	2012-01-05
CEO	Phosphomolybdate (Colorimetric), Inorganic Phosphorus	Clinical Chemistry	Class 1	862.1580	2012-01-05
LFP	Conductivity Rate, Urea Nitrogen	Clinical Chemistry	Class 2	862.1770	2012-01-05
JGS	Electrode, Ion Specific, Sodium	Clinical Chemistry	Class 2	862.1665	2012-01-05
JXM	Enzyme Immunoassay, Benzodiazepine	Clinical Toxicology	Class 2	862.3170	2012-01-05
CEK	Biuret (Colorimetric), Total Protein	Clinical Chemistry	Class 2	862.1635	2012-01-05
CGA	Glucose Oxidase, Glucose	Clinical Chemistry	Class 2	862.1345	2012-01-05
JIY	Photometric Method, Iron (Non-Heme)	Clinical Chemistry	Class 1	862.1410	2012-01-05
JGJ	Photometric Method, Magnesium	Clinical Chemistry	Class 1	862.1495	2012-01-05
CFJ	Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase	Clinical Chemistry	Class 2	862.1440	2012-01-05
JFL	Ph Rate Measurement, Carbon-Dioxide	Clinical Chemistry	Class 2	862.1160	2012-01-05
DCK	C-Reactive Protein, Antigen, Antiserum, And Control	Immunology	Class 2	866.5270	2012-01-05
CGX	Alkaline Picrate, Colorimetry, Creatinine	Clinical Chemistry	Class 2	862.1225	2012-01-05
JFP	Electrode, Ion Specific, Calcium	Clinical Chemistry	Class 2	862.1145	2012-01-05
PPM	General Purpose Reagent	Pathology	Class 1	864.4010	2006-07-24
JXM	Enzyme Immunoassay, Benzodiazepine	Clinical Toxicology	Class 2	862.3170	2013-02-01
JFJ	Catalytic Methods, Amylase	Clinical Chemistry	Class 2	862.1070	2010-05-10
JJW	Urinalysis Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2014-09-24
CEK	Biuret (Colorimetric), Total Protein	Clinical Chemistry	Class 2	862.1635	2011-10-19
MRR	System, Test, Low Density, Lipoprotein	Clinical Chemistry	Class 1	862.1475	2001-09-27
JFY	Enzymatic Method, Creatinine	Clinical Chemistry	Class 2	862.1225	2009-09-16
JIF	Enzymatic Method, Ammonia	Clinical Chemistry	Class 1	862.1065	2012-09-12
LCP	Assay, Glycosylated Hemoglobin	Hematology	Class 2	864.7470	2013-02-01
KRZ	Calibrator For Hemoglobin And Hematocrit Measurement	Hematology	Class 2	864.8165	2013-02-01
CGS	Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes	Clinical Chemistry	Class 2	862.1215	2011-03-14
CIT	Nadh Oxidation/Nad Reduction, Ast/Sgot	Clinical Chemistry	Class 2	862.1100	2011-03-14
CKA	Nadh Oxidation/Nad Reduction, Alt/Sgpt	Clinical Chemistry	Class 1	862.1030	2011-03-14
JXN	Enzyme Immunoassay, Propoxyphene	Clinical Toxicology	Class 2	862.3700	2013-02-01
DEW	Igg, Antigen, Antiserum, Control	Immunology	Class 2	866.5510	2013-02-18
CFN	Method, Nephelometric, Immunoglobulins (G, A, M)	Immunology	Class 2	866.5510	2013-02-18
JJY	Multi-Analyte Controls, All Kinds (Assayed)	Clinical Chemistry	Class 1	862.1660	2013-02-18
DAD	Haptoglobin, Antigen, Antiserum, Control	Immunology	Class 2	866.5460	1977-12-16
CIG	Diazo Colorimetry, Bilirubin	Clinical Chemistry	Class 2	862.1110	2011-12-30
JIS	Calibrator, Primary	Clinical Chemistry	Class 2	862.1150	2011-12-30
JIX	Calibrator, Multi-Analyte Mixture	Clinical Chemistry	Class 2	862.1150	2013-02-01
JIQ	Turbidimetric Method, Protein Or Albumin (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1645	2013-02-01
JIX	Calibrator, Multi-Analyte Mixture	Clinical Chemistry	Class 2	862.1150	2012-09-12
NQD	Cardiac C-Reactive Protein, Antigen, Antiserum, And Control	Immunology	Class 2	866.5270	2012-09-12
MSJ	Apolipoproteins	Clinical Chemistry	Class 1	862.1475	2013-02-01
LEG	Enzyme Immunoassay, Valproic Acid	Clinical Toxicology	Class 2	862.3645	2013-02-01
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2013-02-01
MSJ	Apolipoproteins	Clinical Chemistry	Class 1	862.1475	2013-02-01
JIS	Calibrator, Primary	Clinical Chemistry	Class 2	862.1150	2013-02-04
DIF	Drug Mixture Control Materials	Clinical Toxicology	Class 1	862.3280	2013-02-01
JFM	Enzymatic Method, Bilirubin	Clinical Chemistry	Class 2	862.1110	2016-02-17
JIS	Calibrator, Primary	Clinical Chemistry	Class 2	862.1150	2013-02-01
DCN	System, Test, C-Reactive Protein	Immunology	Class 2	866.5270	2013-02-01
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2013-02-01
DDG	Transferrin, Antigen, Antiserum, Control	Immunology	Class 2	866.5880	2013-02-01
MGA	Alpha-1 Microglobulin, Antigen, Antiserum, Control	Immunology	Class 1	866.5400	2011-08-02
JFM	Enzymatic Method, Bilirubin	Clinical Chemistry	Class 2	862.1110	2012-08-29
DCK	C-Reactive Protein, Antigen, Antiserum, And Control	Immunology	Class 2	866.5270	2013-02-01
LDJ	Enzyme Immunoassay, Cannabinoids	Clinical Toxicology	Class 2	862.3870	2012-10-31
CEK	Biuret (Colorimetric), Total Protein	Clinical Chemistry	Class 2	862.1635	2012-10-31
CFR	Hexokinase, Glucose	Clinical Chemistry	Class 2	862.1345	2012-10-31
JXN	Enzyme Immunoassay, Propoxyphene	Clinical Toxicology	Class 2	862.3700	2012-10-31
JMO	Ferrozine (Colorimetric) Iron Binding Capacity	Clinical Chemistry	Class 1	862.1415	2012-10-31
JZJ	Prealbumin, Antigen, Antiserum, Control	Immunology	Class 1	866.5060	2012-10-31
LDP	Colorimetry, Acetaminophen	Clinical Toxicology	Class 2	862.3030	2012-10-31
DIS	Enzyme Immunoassay, Barbiturate	Clinical Toxicology	Class 2	862.3150	2012-10-31
LCD	Enzyme Immunoassay, Gentamicin	Clinical Toxicology	Class 2	862.3450	2012-10-31
DIP	Enzyme Immunoassay, Diphenylhydantoin	Clinical Toxicology	Class 2	862.3350	2012-10-31
DLZ	Enzyme Immunoassay, Phenobarbital	Clinical Toxicology	Class 2	862.3660	2012-10-31
CDQ	Urease And Glutamic Dehydrogenase, Urea Nitrogen	Clinical Chemistry	Class 2	862.1770	2012-10-31
DMT	Enzymatic Method, Alcohol Dehydrogenase, Ultraviolet	Clinical Toxicology	Class 2	862.3040	2012-10-31
KHQ	Radioassay, Triiodothyronine Uptake	Clinical Chemistry	Class 2	862.1715	2012-10-31
CJW	Bromcresol Purple Dye-Binding, Albumin	Clinical Chemistry	Class 2	862.1035	2012-10-31
KLT	Enzyme Immunoassay, Carbamazepine	Clinical Toxicology	Class 2	862.3645	2012-10-31
JFP	Electrode, Ion Specific, Calcium	Clinical Chemistry	Class 2	862.1145	2012-10-31
CEM	Electrode, Ion Specific, Potassium	Clinical Chemistry	Class 2	862.1600	2012-10-31
DKZ	Enzyme Immunoassay, Amphetamine	Clinical Toxicology	Class 2	862.3100	2012-10-31
DHR	System, Test, Rheumatoid Factor	Immunology	Class 2	866.5775	2012-10-31
CHH	Enzymatic Esterase--Oxidase, Cholesterol	Clinical Chemistry	Class 1	862.1175	2012-10-31
JFM	Enzymatic Method, Bilirubin	Clinical Chemistry	Class 2	862.1110	2012-10-31
JGS	Electrode, Ion Specific, Sodium	Clinical Chemistry	Class 2	862.1665	2012-10-31
DEW	Igg, Antigen, Antiserum, Control	Immunology	Class 2	866.5510	2012-10-31
DKJ	Colorimetry, Salicylate	Clinical Toxicology	Class 2	862.3830	2012-10-31
CGZ	Electrode, Ion-Specific, Chloride	Clinical Chemistry	Class 2	862.1170	2012-10-31
CGS	Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes	Clinical Chemistry	Class 2	862.1215	2012-10-31
CGA	Glucose Oxidase, Glucose	Clinical Chemistry	Class 2	862.1345	2012-10-31
CJY	Azo Dye, Calcium	Clinical Chemistry	Class 2	862.1145	2012-10-31
KXT	Enzyme Immunoassay, Digoxin	Clinical Toxicology	Class 2	862.3320	2012-10-31
DFT	Igm, Antigen, Antiserum, Control	Immunology	Class 2	866.5550	2012-10-31
JFJ	Catalytic Methods, Amylase	Clinical Chemistry	Class 2	862.1070	2012-10-31
CHW	Titrimetric With Edta And Indicator, Calcium	Clinical Chemistry	Class 2	862.1145	2012-10-31
CFJ	Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase	Clinical Chemistry	Class 2	862.1440	2012-10-31
CDT	Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides	Clinical Chemistry	Class 1	862.1705	2012-10-31
LEG	Enzyme Immunoassay, Valproic Acid	Clinical Toxicology	Class 2	862.3645	2012-10-31
JXM	Enzyme Immunoassay, Benzodiazepine	Clinical Toxicology	Class 2	862.3170	2012-10-31
DCK	C-Reactive Protein, Antigen, Antiserum, And Control	Immunology	Class 2	866.5270	2012-10-31
KLS	Enzyme Immunoassay, Theophylline	Clinical Toxicology	Class 2	862.3880	2012-10-31
KXS	Radioimmunoassay, Methaqualone	Clinical Toxicology	Class 2	862.3630	2012-10-31
JFL	Ph Rate Measurement, Carbon-Dioxide	Clinical Chemistry	Class 2	862.1160	2012-10-31
DDG	Transferrin, Antigen, Antiserum, Control	Immunology	Class 2	866.5880	2012-10-31
CGX	Alkaline Picrate, Colorimetry, Creatinine	Clinical Chemistry	Class 2	862.1225	2012-10-31
GTQ	Antistreptolysin - Titer/Streptolysin O Reagent	Microbiology	Class 1	866.3720	2012-10-31
CZP	Iga, Antigen, Antiserum, Control	Immunology	Class 2	866.5510	2012-10-31
CJE	Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes	Clinical Chemistry	Class 2	862.1050	2012-10-31
JOB	Hexane Extraction, Fluorescence, Vitamin E	Clinical Chemistry	Class 1	862.1815	2012-10-31
CIG	Diazo Colorimetry, Bilirubin	Clinical Chemistry	Class 2	862.1110	2012-10-31
CHI	Lipase-Esterase, Enzymatic, Photometric, Lipase	Clinical Chemistry	Class 1	862.1465	2012-10-31
DJR	Enzyme Immunoassay, Methadone	Clinical Toxicology	Class 2	862.3620	2012-10-31
CIT	Nadh Oxidation/Nad Reduction, Ast/Sgot	Clinical Chemistry	Class 2	862.1100	2012-10-31
JJE	Analyzer, Chemistry (Photometric, Discrete), For Clinical Use	Clinical Chemistry	Class 1	862.2160	2012-10-31
DIO	Enzyme Immunoassay, Cocaine And Cocaine Metabolites	Clinical Toxicology	Class 2	862.3250	2012-10-31
DJG	Enzyme Immunoassay, Opiates	Clinical Toxicology	Class 2	862.3650	2012-10-31
LCM	Enzyme Immunoassay, Phencyclidine	Unknown	Class U	N/A	2012-10-31
LCP	Assay, Glycosylated Hemoglobin	Hematology	Class 2	864.7470	2012-10-31
KLI	Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine	Clinical Chemistry	Class 2	862.1700	2012-10-31
LCR	Fluorescent Immunoassay, Tobramycin	Clinical Toxicology	Class 2	862.3900	2012-10-31
DDT	Alpha-2-Macroglobulin, Rhodamine, Antigen, Antiserum, Control	Immunology	Class 2	866.5620	2012-10-31
JHW	U.V. Method, Cpk Isoenzymes	Clinical Chemistry	Class 2	862.1215	2012-10-31
DCF	Albumin, Antigen, Antiserum, Control	Immunology	Class 2	866.5040	2012-10-31
CKA	Nadh Oxidation/Nad Reduction, Alt/Sgpt	Clinical Chemistry	Class 1	862.1030	2012-10-31
JGG	L-Leucine-4-Nitroanilide (Colorimetric), Leucine Arylamidase	Clinical Chemistry	Class 1	862.1460	2012-10-31
DEM	Alpha-1-Antitrypsin, Antigen, Antiserum, Control	Immunology	Class 2	866.5130	2011-08-02
DDS	Prealbumin, Fitc, Antigen, Antiserum, Control	Immunology	Class 1	866.5060	2013-02-01
JIX	Calibrator, Multi-Analyte Mixture	Clinical Chemistry	Class 2	862.1150	2013-02-01
DEW	Igg, Antigen, Antiserum, Control	Immunology	Class 2	866.5510	2013-02-01
DIO	Enzyme Immunoassay, Cocaine And Cocaine Metabolites	Clinical Toxicology	Class 2	862.3250	2013-02-01
DLJ	Calibrators, Drug Specific	Clinical Toxicology	Class 2	862.3200	2013-02-01
LDJ	Enzyme Immunoassay, Cannabinoids	Clinical Toxicology	Class 2	862.3870	2013-02-01
JJY	Multi-Analyte Controls, All Kinds (Assayed)	Clinical Chemistry	Class 1	862.1660	2013-02-01
DKC	Alcohol Control Materials	Clinical Toxicology	Class 1	862.3280	2013-02-04
LCM	Enzyme Immunoassay, Phencyclidine	Unknown	Class U	N/A	2013-02-01
JJY	Multi-Analyte Controls, All Kinds (Assayed)	Clinical Chemistry	Class 1	862.1660	2013-02-01
DCK	C-Reactive Protein, Antigen, Antiserum, And Control	Immunology	Class 2	866.5270	2013-02-01
JFY	Enzymatic Method, Creatinine	Clinical Chemistry	Class 2	862.1225	2016-02-17
CGX	Alkaline Picrate, Colorimetry, Creatinine	Clinical Chemistry	Class 2	862.1225	2013-05-16
JIX	Calibrator, Multi-Analyte Mixture	Clinical Chemistry	Class 2	862.1150	2013-05-16
DLJ	Calibrators, Drug Specific	Clinical Toxicology	Class 2	862.3200	2013-02-01
KXT	Enzyme Immunoassay, Digoxin	Clinical Toxicology	Class 2	862.3320	2013-02-01
DGC	Ige, Antigen, Antiserum, Control	Immunology	Class 2	866.5510	2013-02-01
CKA	Nadh Oxidation/Nad Reduction, Alt/Sgpt	Clinical Chemistry	Class 1	862.1030	2004-07-29
JIX	Calibrator, Multi-Analyte Mixture	Clinical Chemistry	Class 2	862.1150	2013-02-01
DFT	Igm, Antigen, Antiserum, Control	Immunology	Class 2	866.5550	2013-02-01
CZP	Iga, Antigen, Antiserum, Control	Immunology	Class 2	866.5510	2013-02-01
DEW	Igg, Antigen, Antiserum, Control	Immunology	Class 2	866.5510	2013-02-01
CHH	Enzymatic Esterase--Oxidase, Cholesterol	Clinical Chemistry	Class 1	862.1175	2004-07-29
DKB	Calibrators, Drug Mixture	Clinical Toxicology	Class 2	862.3200	2013-02-01
DIS	Enzyme Immunoassay, Barbiturate	Clinical Toxicology	Class 2	862.3150	2013-02-01
DLJ	Calibrators, Drug Specific	Clinical Toxicology	Class 2	862.3200	2013-02-01
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2013-02-15
CEK	Biuret (Colorimetric), Total Protein	Clinical Chemistry	Class 2	862.1635	2013-02-15
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2011-12-30
JMO	Ferrozine (Colorimetric) Iron Binding Capacity	Clinical Chemistry	Class 1	862.1415	2011-12-30
CZP	Iga, Antigen, Antiserum, Control	Immunology	Class 2	866.5510	2013-02-01
CGX	Alkaline Picrate, Colorimetry, Creatinine	Clinical Chemistry	Class 2	862.1225	2011-12-30
CGA	Glucose Oxidase, Glucose	Clinical Chemistry	Class 2	862.1345	2015-01-05
JIS	Calibrator, Primary	Clinical Chemistry	Class 2	862.1150	2013-02-04
LCP	Assay, Glycosylated Hemoglobin	Hematology	Class 2	864.7470	2014-08-18
JJY	Multi-Analyte Controls, All Kinds (Assayed)	Clinical Chemistry	Class 1	862.1660	2013-02-01
CFN	Method, Nephelometric, Immunoglobulins (G, A, M)	Immunology	Class 2	866.5510	2012-08-14
JIX	Calibrator, Multi-Analyte Mixture	Clinical Chemistry	Class 2	862.1150	2012-08-14
DEW	Igg, Antigen, Antiserum, Control	Immunology	Class 2	866.5510	2011-10-17
KHE	Reagent, Occult Blood	Hematology	Class 2	864.6550	2010-04-29
KNK	Acid, Uric, Uricase (Colorimetric)	Clinical Chemistry	Class 1	862.1775	2011-12-30
GGK	Products, Red-Cell Lysing Products	Hematology	Class 1	864.8540	1977-12-14
NQD	Cardiac C-Reactive Protein, Antigen, Antiserum, And Control	Immunology	Class 2	866.5270	2008-05-29
JCB	Detergent	Pathology	Class 1	864.4010	1977-12-14
JZH	Factor B, Antigen, Antiserum, Control	Immunology	Class 2	866.5320	2013-02-01
DHR	System, Test, Rheumatoid Factor	Immunology	Class 2	866.5775	2013-01-31
DJR	Enzyme Immunoassay, Methadone	Clinical Toxicology	Class 2	862.3620	2013-02-01

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

BECKMAN COULTER, INC.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3004198394	BECKMAN COULTER, INC.	INDIANAPOLIS, IN, US
3021394862	Beckman Coulter Biomedical GmbH	Baierbrunn Bavaria, DE
3008629785	Beckman Coulter, Inc.	Hebron, KY, US
3006677029	Beckman Coulter Biomedical GmbH	Munchen Bavaria, DE
3003244710	Beckman Coulter Biotechnology (Suzhou) Co., Ltd	Suzhou Jiangsu, CN

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K990531	Ortho-Clinical Diagnostics, Inc.	VITROS IMMUNODIAGNOSTIC PRODUCTS ONCOLOGY CONTROLS	1999-03-12
K982637	Diagnostic Products Corp.	IMMULITE PSA CONTROL MODULE, MODEL LPSCM	1998-08-12
K012468	Dade Behring, Inc.	MODIFICATION TO N/T PROTEIN CONTROL SL	2001-09-04
K832444	Stanbio Laboratory	ENZYMATIC TRIGLYCERIDES #2000	1983-08-31
K133067	Siemens Healthcare Diagnostics, Inc.	ADVIA CHEMISTRY TRIGLYCERIDES_2 (TRIG_2) REAGENT	2013-11-22

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0009-2009	Roche Diagnostics Corp.	2	Roche Diagnostics STFR Tina-quant Soluble Transferrin Receptor, COBAS INTEGRA, cobas c systems, Roche Diagnostics, Indianapolis, IN.; 20763454122. An in-vitro diagnostic reagent system intended for use on COBAS Integra systems for the quantitative determination of soluable transferrin receptor in serum and plasma.
Z-0164-2015	Siemens Healthcare Diagnostics, Inc	2	Siemens Calibrator E; SMN 10309079 (2 pack), SMN 10321075 (6 pack), SMN 10335532 (6 pack Ref)
Z-0010-2009	Roche Diagnostics Corp.	1	Roche Diagnostics HDLC3, HDL-Cholesterol Plus 3rd Generation, COBAS INTEGRA, cobas c systems, Roche Diagnostics, Indianapolis, IN.; 04399803190. An in-vitro diagnostic reagent system intended for use on COMAS Integra systems for the quantitative determination of HDL-cholesterol in serum and plasma.
Z-0024-2007	Abbott Diagnostic International, Ltd. Carr 2 Km 58.0 Cruce Davila	2	FSH Calibrators (LN 9C06-01), for in vitro diagnostic use.
Z-0024-2015	Siemens Healthcare Diagnostics, Inc.	2	Dimension Vista Mass CKMB Isoenzyme Calibrator (MMB CAL) an in vitro diagnostic product for the calibration of Creatine Kinase MB Isoenzyme (MMB) method on the Dimension Vista System.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2050010. Last updated year: 2026. Please use registration number 2050010 when referencing this establishment in official correspondence.