Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9680746

FEI Number

1000206808

Entity Name

Beckman Coulter Ireland Inc

City/State/Country

O CALLAGHANS MILLS Clare, IE

Establishment Address

LISMEEHAN, O CALLAGHANS MILLS Clare --, IE

Establishment Type(s)

Manufacture Medical Device

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

K925339

PMA Number

N/A

All Registered Proprietary Names

Access AMH (P/N: B13127 IE MFG) OSR61205 UIBC Access TSH (3rd IS) (P/N: B63284 MN and IE MFG) DxI 9000 Immunoassay Analyzer (P/N: C11137) Access TSH (3rd IS) (P/N: C28643 MN MFG) OSR6102 ALBUMIN OSR6202 ALBUMIN OSR6602 ALBUMIN OSR61155 CK-MB ODR3021 SERUM PROTEIN MULTI-CALIBRATOR 1 OSR61172 IgG OSR61172x IgG ODR3022 APO A1 & B CALIBRATOR OSR6142 APO A1 OSR6151 β-2 MICROGLOBULIN Access Free T3 (P/N: A13422 MN and IE MFG) OSR6119 GLUTAMYLTRANSFERASE (GGT) OSR6219 GAMMA-GLUTAMYLTRANSFERASE (GGT) OSR6179 CK (NAC) OSR6279 CK (NAC) OSR61118 TRIGLYCERIDE OSR60118 TRIGLYCERIDE OSR66118 TRIGLYCERIDE OSR61203 FERRITIN OSR6221 GLUCOSE OSR6121 GLUCOSE OSR6621 GLUCOSE OSR6695 HDL-CHOLESTEROL OSR6295 HDL-CHOLESTEROL OSR6195 HDL-CHOLESTEROL ODC0023 HDL CHOLESTEROL CALIBRATOR OSR6193 LACTATE Access CK-MB (P/N: 386371 MN and IE MFG) Access CK-MB Calibrators (P/N: 386372 MN MFG) Access hsTnI (P/N: B52699 MN and IE MFG) System calibrator 66300X Bicarbonate calibrator ODC0019 Access TSH (3rd IS) Calibrators (P/N: B63285 MN MFG) Access TSH (3rd IS) (P/N: B63284 MN and IE MFG) OSR6209 AST OSR6609 AST OSR6109 AST OSR6509 AST Access Myoglobin (P/N: 973243 MN and IE MFG) Access Myoglobin Calibrators (P/N: 973244 MN MFG) OSR6160 C4 476841 Lactate Dehydrogenase Reagent (LD 2 x 300) 442655 Lactate Dehydrogenase Reagent (LD 2 x 200) 442660 Lactate Dehydrogenase Reagent (LD-P 2 x 200) A95550 Lactate Reagent (LACT 2 x 50) SYNCHRON Lactate OSR6127 LACTATE DEHYDROGENASE OSR6227 LACTATE DEHYDROGENASE OSR61173 IgM Access TPO Antibody (P/N: A12985 MN and IE MFG) ODR3029 PREALBUMIN CALIBRATOR Access Vitamin B12 (P/N: 33000 MN and IE MFG) Access Vitamin B12 Calibrators (P/N: 33005 MN MFG) Access Vitamin B12 S0 Calibrator (P/N: 33006 MN MFG) OSR6134 UREA/UREA NITROGEN OSR6234 UREA/UREA NITROGEN OSR6634 UREA/UREA NITROGEN OSR6147 CRP iChemVELOCITY Automated Urine Chemistry System (800-7167) Stand-Alone iChemVELOCITY (800-7719) iChemVELOCITY Automated Urine Chemistry System w load/unload (800-7166) iChemVELOCITY Computerless (800-3530) Back-Integrated iChemVELOCITY (800-7720) iChemVELOCITY Urine Chemistry Strips (800-7212) UA Win10 Kit (C52900) Access Intact PTH (P/N: A16972 MN and IE MFG) Access Total bhCG (5th IS) (P/N: A85264 MN and IE MFG) Access Total bhCG (5th IS) Calibrators (P/N: B11754 MN MFG) Access AMH (P/N: B13127 IE MFG) Access AMH QC (P/N: B13129) Access AMH Calibrators (P/N: B13128) OSR6122 INORGANIC PHOSPHOROUS OSR6222 INORGANIC PHOSPHOROUS ODC0003 Control Serum 1 ODC0004 Control Serum 2 ODC0005 HDL/LDL Cholesterol Control Serum (Level 1-2) 3x5 mL OSR6175 PREALBUMIN Access 25(OH) Vitamin D Total for Use on the Access 2 Immunoassay System (P/N: B24838 MN and IE MFG) Access 25(OH) Vitamin D Total Calibrators for Use on the Access 2 Immunoassay System. (P/N: B24839 MN MFG) OSR6189x MAGNESIUM OSR6189 MAGNESIUM OSR6165 HAPTOGLOBIN 988413 Haptoglobin Reagent (HPT 2 x 100) QUANTIPLATE OR ENDOPLATE TM HA OSR61117 CALCIUM ARSERAZO OSR66117 CALCIUM ARSENAZO OSR60117 CALCIUM ARSENAZO OSR65117 CALCIUM (Arsenazo) OSR6162 α-1 ACIDGLYCOPROTEIN OSR6163 α-1 ANTITRYPSIN DR0090 URINE CHEMISTRY CALIBRATOR DR0091 URINE CREATININE CALIBRATOR DR0070-1 LYOPHILIZED CHEMISTRY CALIBRATOR LEVEL 1 DR0070-2 LYOPHILIZED CHEMISTRY CALIBRATOR LEVEL 2 ODR3023 SERUM PROTEIN MULTI-CALIBRATOR 2 OSR6114 CHOLINESTERASE Access Hybritech free PSA (P/N: 37210 MN and IE MFG) Access Hybritech Free PSA Calibrators (P/N: 37215 MN MFG) Access Hybritech free PSA (P/N: C22846 MN MFG) Access 25(OH) Vitamin D Total (A98856 MN and IE MFG) Access 25(OH) Vitamin D Total (C28646 MN MFG) Access Total ?hCG (5th IS) (P/N: A85264 MN and IE MFG) Access Total ?hCG (5th IS) (P/N: C28645 MN MFG) B00389 HbA1c Access Intact PTH (P/N: A16972 MN and IE MFG) Access Intact PTH Calibrators (P/N: A16953 FR MFG) ODC0027 CRP LATEX CALIBRATOR HIGHLY SENSITIVE (HS) SET ODC0026 CRP LATEX CALIBRATOR NORMANL (N) SET OSR6199 CRP LATEX Ceruloplasmin OSR6106 ALPHA-AMYLASE OSR6006 ALPHA-AMYLASE Access TPO Antibody Calibrators (P/N: A18227 FR MFG) Access TPO Antibody (P/N: A12985 MN and IE MFG) 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 Access Ferritin (P/N: C22490) Access Ferritin (P/N: 33020) ACCESS anti-HBc IgM, Access anti-HBc IgM Calibrator, Access anti-HBc IgM QC OSR6678 CREATININE OSR6178 CREATININE OSR6137 BICARBONATE OSR6237 BICARBONATE OSR6537 BICARBONATE OSR6637 BICARBONATE ODC0028 RF LATEX CALIBRATOR OSR61105 RF LATEX Access Prolactin (P/N: 33530 MN and IE MFG) Access Prolactin Calibrators (P/N: 33535 MN MFG) Access anti-HAV Calibrator Access anti-HAV Access anti-HAV QC Access Hybritech PSA Sample Diluent (P/N: 37206 MN MFG) Access Hybritech PSA (P/N: 37200 MN and IE MFG) Access Hybritech PSA Calibrators (P/N: 37205 MN MFG) Access Hybritech PSA (P/N: C22845 MN MFG) Access HBsAg Calibrator Access HBsAg Confirmatory Access HBsAg QC Access HBsAg 447480 IMMAGE Immunochemistry Systems DNB Antideoxyribonuclease-B Reagent 447620 IMMAGE Immunochemistry Systems ASO Anti-Streptolysin Reagent 469165 Antistreptolysin-O Reagent (ASO- 2 x 100) OSR6194 ASO 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 OSR6111 DIRECT BILIRUBIN OSR6611 DIRECT BILIRUBIN OSR6511 DIRECT BILIRUBIN OSR6211 DIRECT BILIRUBIN OSR6112 TOTAL BILIRUBIN OSR6612 TOTAL BILIRUBIN OSR6512 TOTAL BILIRUBIN OSR6212 TOTAL BILIRUBIN Access Free T4 (P/N: 33880 MN and IE MFG) Access Free T4 Calibrators (P/N: 33885 MN MFG) ACCESS anti-HAV IgM QC 2x4 mL (3 ea) US (D25836) ACCESS anti-HAV IgM 2x100 DET US (D25834) ACCESS anti-HAV IgM Calibrator 1x2 mL US (D25835) Access hLH Calibrators (P/N: 33515 MN MFG) Access hLH (P/N: 33510 MN and IE MFG) 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) Access Folate (P/N: A98032 MN and IE MFG) OSR6186 IRON OSR6286 IRON A53722 Synchron Cholinesterase (CHEX) Reagent OSR6604 ALP OSR6004 ALP OSR6104 ALP OSR6504 ALP OSR6204 ALP Access hsTnI (P/N: B52699 MN and IE MFG) Access Ferritin Calibrators (P/N: 33025) Access Ferritin (P/N: 33020) OSR6296 LDL-CHOLESTEROL OSR6196 LDL-CHOLESTEROL ODC0024 LDL CHOLESTEROL CALIBRATOR B38858 URINE/CSF ALBUMIN B38859 URINE/CSF ALBUMIN CALIBRATOR B46435 URINE/CSF ALBUMIN OSR6607 ALT OSR6107 ALT

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
PQO	Anti-Müllerian Hormone Test System	Clinical Chemistry	Class 2	862.1092	2023-02-08
JMO	Ferrozine (Colorimetric) Iron Binding Capacity	Clinical Chemistry	Class 1	862.1415	2012-12-20
JLW	Radioimmunoassay, Thyroid-Stimulating Hormone	Clinical Chemistry	Class 2	862.1690	2022-12-21
JJE	Analyzer, Chemistry (Photometric, Discrete), For Clinical Use	Clinical Chemistry	Class 1	862.2160	2022-12-21
CIX	Bromcresol Green Dye-Binding, Albumin	Clinical Chemistry	Class 2	862.1035	2009-08-17
JHY	Colorimetric Method, Cpk Or Isoenzymes	Clinical Chemistry	Class 2	862.1215	2009-08-13
JIX	Calibrator, Multi-Analyte Mixture	Clinical Chemistry	Class 2	862.1150	2009-08-17
CFN	Method, Nephelometric, Immunoglobulins (G, A, M)	Immunology	Class 2	866.5510	2012-12-20
JHN	Turbidimetric Method, Lipoproteins	Clinical Chemistry	Class 1	862.1475	2009-08-13
JZG	System, Test, Beta-2-Microglobulin Immunological	Immunology	Class 2	866.5630	2009-08-17
CDP	Radioimmunoassay, Total Triiodothyronine	Clinical Chemistry	Class 2	862.1710	1999-04-28
JQB	Kinetic Method, Gamma-Glutamyl Transpeptidase	Clinical Chemistry	Class 1	862.1360	2004-07-29
CGS	Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes	Clinical Chemistry	Class 2	862.1215	2012-12-20
CDT	Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides	Clinical Chemistry	Class 1	862.1705	2009-09-22
DBF	Ferritin, Antigen, Antiserum, Control	Immunology	Class 2	866.5340	2009-12-31
CFR	Hexokinase, Glucose	Clinical Chemistry	Class 2	862.1345	2012-12-20
LBS	Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl	Clinical Chemistry	Class 1	862.1475	2012-01-18
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2012-01-18
KHP	Acid, Lactic, Enzymatic Method	Clinical Chemistry	Class 1	862.1450	1998-06-02
JIS	Calibrator, Primary	Clinical Chemistry	Class 2	862.1150	2008-09-18
JHX	Fluorometric Method, Cpk Or Isoenzymes	Clinical Chemistry	Class 2	862.1215	2008-09-18
MMI	Immunoassay Method, Troponin Subunit	Clinical Chemistry	Class 2	862.1215	2023-12-20
JIX	Calibrator, Multi-Analyte Mixture	Clinical Chemistry	Class 2	862.1150	2014-11-13
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2014-11-13
JIS	Calibrator, Primary	Clinical Chemistry	Class 2	862.1150	2016-09-01
JLW	Radioimmunoassay, Thyroid-Stimulating Hormone	Clinical Chemistry	Class 2	862.1690	2016-09-01
CIT	Nadh Oxidation/Nad Reduction, Ast/Sgot	Clinical Chemistry	Class 2	862.1100	2009-08-13
DDR	Myoglobin, Antigen, Antiserum, Control	Immunology	Class 2	866.5680	2012-09-24
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2012-09-24
DBI	Complement C4, Antigen, Antiserum, Control	Immunology	Class 2	866.5240	2009-08-13
CFJ	Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase	Clinical Chemistry	Class 2	862.1440	2004-07-29
CFN	Method, Nephelometric, Immunoglobulins (G, A, M)	Immunology	Class 2	866.5510	2009-08-13
JZO	System, Test, Thyroid Autoantibody	Immunology	Class 2	866.5870	2024-08-15
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2012-12-20
CDD	Radioassay, Vitamin B12	Clinical Chemistry	Class 2	862.1810	2008-08-14
CDQ	Urease And Glutamic Dehydrogenase, Urea Nitrogen	Clinical Chemistry	Class 2	862.1770	2012-12-21
DCN	System, Test, C-Reactive Protein	Immunology	Class 2	866.5270	2009-08-13
CDM	Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1785	2014-08-18
JJB	Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1115	2014-08-18
JMT	Diazo (Colorimetric), Nitrite (Urinary, Non-Quant)	Clinical Chemistry	Class 1	862.1510	2014-08-18
JMA	Acid, Ascorbic, 2,4-Dinitrophenylhydrazine (Spectrophotometric)	Clinical Chemistry	Class 1	862.1095	2014-08-18
JIO	Blood, Occult, Colorimetric, In Urine	Hematology	Class 2	864.6550	2014-08-18
LJX	Test, Urine Leukocyte	Hematology	Class 1	864.7675	2014-08-18
JIL	Method, Enzymatic, Glucose (Urinary, Non-Quantitative)	Clinical Chemistry	Class 2	862.1340	2014-08-18
JRE	Refractometer For Clinical Use	Clinical Chemistry	Class 1	862.2800	2014-08-18
JIR	Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1645	2014-08-18
KQO	Automated Urinalysis System	Clinical Chemistry	Class 1	862.2900	2014-08-18
JIN	Nitroprusside, Ketones (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1435	2014-08-18
CEN	Dye-Indicator, Ph (Urinary, Non-Quantitative)	Clinical Chemistry	Class 1	862.1550	2014-08-18
CEW	Radioimmunoassay, Parathyroid Hormone	Clinical Chemistry	Class 2	862.1545	2024-03-07
DHA	System, Test, Human Chorionic Gonadotropin	Clinical Chemistry	Class 2	862.1155	2014-06-20
JIX	Calibrator, Multi-Analyte Mixture	Clinical Chemistry	Class 2	862.1150	2014-06-20
PQO	Anti-Müllerian Hormone Test System	Clinical Chemistry	Class 2	862.1092	2017-12-12
CEO	Phosphomolybdate (Colorimetric), Inorganic Phosphorus	Clinical Chemistry	Class 1	862.1580	2012-12-20
JJY	Multi-Analyte Controls, All Kinds (Assayed)	Clinical Chemistry	Class 1	862.1660	2018-12-06
DDS	Prealbumin, Fitc, Antigen, Antiserum, Control	Immunology	Class 1	866.5060	2010-02-11
MRG	System, Test, Vitamin D	Clinical Chemistry	Class 2	862.1825	2015-01-22
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2015-01-22
JGJ	Photometric Method, Magnesium	Clinical Chemistry	Class 1	862.1495	2012-12-20
DAD	Haptoglobin, Antigen, Antiserum, Control	Immunology	Class 2	866.5460	1977-12-16
CJY	Azo Dye, Calcium	Clinical Chemistry	Class 2	862.1145	2012-01-27
LKL	Alpha-1-Acid-Glycoprotein, Antigen, Antiserum, Control	Immunology	Class 1	866.5420	1997-06-02
DEM	Alpha-1-Antitrypsin, Antigen, Antiserum, Control	Immunology	Class 2	866.5130	2012-12-21
JIX	Calibrator, Multi-Analyte Mixture	Clinical Chemistry	Class 2	862.1150	2013-04-10
JIX	Calibrator, Multi-Analyte Mixture	Clinical Chemistry	Class 2	862.1150	2013-04-10
JIX	Calibrator, Multi-Analyte Mixture	Clinical Chemistry	Class 2	862.1150	2012-12-21
DIH	Colorimetry, Cholinesterase	Clinical Toxicology	Class 1	862.3240	2009-08-14
MTG	Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions	Unknown	Class 3	N/A	2008-09-18
MRG	System, Test, Vitamin D	Clinical Chemistry	Class 2	862.1825	2023-01-26
DHA	System, Test, Human Chorionic Gonadotropin	Clinical Chemistry	Class 2	862.1155	2022-12-30
LCP	Assay, Glycosylated Hemoglobin	Hematology	Class 2	864.7470	2013-12-16
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2013-12-16
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2008-08-14
CEW	Radioimmunoassay, Parathyroid Hormone	Clinical Chemistry	Class 2	862.1545	2008-08-14
JIT	Calibrator, Secondary	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
DDB	Ceruloplasmin, Antigen, Antiserum, Control	Immunology	Class 2	866.5210	2017-01-18
CIW	Starch-Dye Bound Polymer, Amylase	Clinical Chemistry	Class 2	862.1070	2009-08-17
JZO	System, Test, Thyroid Autoantibody	Immunology	Class 2	866.5870	1988-06-17
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	1988-06-17
PPM	General Purpose Reagent	Pathology	Class 1	864.4010	2006-07-24
JMG	Radioimmunoassay (Two-Site Solid Phase), Ferritin	Immunology	Class 2	866.5340	2024-03-22
SEI	Qualitative And Quantitative Hepatitis B Virus Antibody Assays	Microbiology	Class 2	866.3173	2026-03-27
CGX	Alkaline Picrate, Colorimetry, Creatinine	Clinical Chemistry	Class 2	862.1225	2012-12-20
KHS	Enzymatic, Carbon-Dioxide	Clinical Chemistry	Class 2	862.1160	2014-12-09
DHR	System, Test, Rheumatoid Factor	Immunology	Class 2	866.5775	2012-12-20
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2012-12-20
CFT	Radioimmunoassay, Prolactin (Lactogen)	Clinical Chemistry	Class 1	862.1625	2008-08-14
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2025-12-15
LOL	Hepatitis A Test (Antibody And Igm Antibody)	Microbiology	Class 2	866.3310	2025-12-15
QCH	Assayed Quality Control Material For Clinical Microbiology Assays	Microbiology	Class 2	866.3920	2025-12-15
LTJ	Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers	Immunology	Class 2	866.6010	2006-09-05
MTF	Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer	Unknown	Class 3	N/A	2006-09-05
LOM	Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)	Microbiology	Class 2	866.3172	2025-12-15
GTQ	Antistreptolysin - Titer/Streptolysin O Reagent	Microbiology	Class 1	866.3720	2004-07-29
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
CIG	Diazo Colorimetry, Bilirubin	Clinical Chemistry	Class 2	862.1110	2012-12-20
CIG	Diazo Colorimetry, Bilirubin	Clinical Chemistry	Class 2	862.1110	2012-12-20
JIS	Calibrator, Primary	Clinical Chemistry	Class 2	862.1150	2008-09-18
CEC	Radioimmunoassay, Free Thyroxine	Clinical Chemistry	Class 2	862.1695	2008-09-18
LOL	Hepatitis A Test (Antibody And Igm Antibody)	Microbiology	Class 2	866.3310	2026-02-11
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2026-02-11
QCH	Assayed Quality Control Material For Clinical Microbiology Assays	Microbiology	Class 2	866.3920	2026-02-11
CEP	Radioimmunoassay, Luteinizing Hormone	Clinical Chemistry	Class 1	862.1485	2002-04-24
GGK	Products, Red-Cell Lysing Products	Hematology	Class 1	864.8540	1977-12-14
CGN	Acid, Folic, Radioimmunoassay	Clinical Chemistry	Class 2	862.1295	2023-08-31
JIY	Photometric Method, Iron (Non-Heme)	Clinical Chemistry	Class 1	862.1410	2012-12-20
DIH	Colorimetry, Cholinesterase	Clinical Toxicology	Class 1	862.3240	2012-01-05
CJE	Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes	Clinical Chemistry	Class 2	862.1050	2012-12-20
MMI	Immunoassay Method, Troponin Subunit	Clinical Chemistry	Class 2	862.1215	2018-07-16
JMG	Radioimmunoassay (Two-Site Solid Phase), Ferritin	Immunology	Class 2	866.5340	2007-06-07
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2012-12-20
LBS	Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl	Clinical Chemistry	Class 1	862.1475	2012-12-20
DCF	Albumin, Antigen, Antiserum, Control	Immunology	Class 2	866.5040	2014-12-03
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2014-12-03
CKA	Nadh Oxidation/Nad Reduction, Alt/Sgpt	Clinical Chemistry	Class 1	862.1030	2012-12-20

Official Correspondent

No official correspondent registered.

US Agent Details

Ian Pilcher Business: Beckman Coulter, Inc. Email: ipilcher@beckman.com Phone: (443) 3506459

Related Public Records

Same Entity

BECKMAN COULTER, INC.

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

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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
DEN150057	Roche Diagnostics	Elecsys AMH, AMH CalSet, PreciControl AMH, AMH CalCheck 5	2016-12-19
K850376	Terumo Medical Corp.	TERUMO SENSIBEAD EIA TSH KIT	1985-03-04
K843395	Hybritech, Inc.	ENCORE TSH REAGENT	1984-10-11
K854087	Organon Teknika Corp.	NML TSH IRMA	1985-10-25
K151792	Siemens Healthcare Diagnostics, Inc.	Trinidad IM Thyroid Stimulating Hormone (TSH) Assay, Trinidad IM TSH Calibrators, Trinidad Immunoassay (IM) System	2015-11-20

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0022-2025	Qualigen Inc	2	FastPack TSH Calibrator Kit, REF: 25000024, For use in conjunction with the FastPack IP TSH Immunoassay and FastPack IP System Analyzer
Z-0044-2020	Roche Diagnostics Operations, Inc.	2	AssayTip/AssayCup Tray-used on the cobas e 801 module which is a part of the cobas c 8000 MODULAR Analyzer Series (IVD for in vitro determination of analytes in human body fluids) Catalog Number: 5694302001
Z-0072-2017	Siemens Healthcare Diagnostics, Inc.	2	ADVIA Centaur XPT Immunoassay System
Z-0008-06	Abbott Laboratories, Inc	1	ARCHITECT c800 for Conventional Units and for SI Units, Version 5.00.
Z-0008-2024	Ortho-Clinical Diagnostics, Inc.	1	Proboscis/Piston Assembly, Part Number J55375, for VITROS 5,1 FS Chemistry System (Product Code 6801375), VITROS 5,1 Chemistry System (Refurbished) (Product Code 6801890), VITROS 3600 Immunodiagnostic System (Product Code 6802783), VITROS 3600 Immunodiagnostic System (Refurbished) (Product Code 6802914), VITROS 4600 Chemistry System (Product Code 6802445), VITROS 4600 Chemistry System (Refurbished) (Product Code 6900440), VITROS 5600 Integrated System (Product Code 6802413), VITROS 5600 Integrated System (Refurbished) (Product Code 6802915), VITROS XT 3400 Chemistry System (Product Code 6844458), and VITROS XT 7600 Integrated System (Product Code 6844461)

Similar Registrations

Registration Number	Establishment Name	Location
8023018	Immunotech SAS, a Beckman Coulter company	MARSEILLE, CEDEX 9 Bouches-du-Rhone, FR
1219913	Siemens Healthcare Diagnostics Inc.	E Walpole, MA, US
9610126	ROCHE DIAGNOSTICS GMBH	MANNHEIM Baden-Wurttemberg, DE
3022178699	IMMUNOCENTRIX CORPORATION	Canoga Park, CA, US
2432235	Siemens Healthcare Diagnostics Inc.	Tarrytown, NY, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9680746. Last updated year: 2026. Please use registration number 9680746 when referencing this establishment in official correspondence.