Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2122870

FEI Number

2122870

Entity Name

BECKMAN COULTER, INC.

City/State/Country

CHASKA, MN, US

Establishment Address

1000 LAKE HAZELTINE DR., CHASKA, MN 55318, US

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

K061282

PMA Number

N/A

All Registered Proprietary Names

Access Sensitive Estradiol (P/N: B84493 IE MFG) Access Estradiol (33540 MN ans IE MFG) Access Prolactin (P/N: 33530 MN and IE MFG) Access Prolactin Calibrators (P/N: 33535 MN MFG) Access Intact PTH (P/N: A16972 MN and IE MFG) Access Intact PTH Calibrators (P/N: A16953 FR MFG) Access Testosterone (P/N: 33560) Access Testosterone Calibrators (P/N: 33565) Access Rubella IgG (P/N: 34430) Access Rubella IgG QC (P/N: 34439) Access Rubella IgG Calibrators (P/N: 34435) Access hsTnI (P/N: B52699 MN and IE MFG) Access Intrinsic Factor Ab (P/N: 387992) Access AFP (P/N: 33211) Access AFP Sample Diluent (P/N: 33216) Access BR Monitor (P/N: 387620) Access TPO Antibody (P/N: A12985 MN and IE MFG) Access Ostase (P/N: 37300) Access Hybritech PSA QC (P/N: 37209) Access Intrinsic Factor Antibody (P/N: 387992) Access Intrinsic Factor Antibody QC (P/N: 387999) Access Intrinsic Factor Antibody Calibrators (P/N: 387993) Access Total T3 (P/N: 33830) Access Total T3 Calibrators (P/N: 33835) Access DHEA-S Calibrators (P/N: A10827) Access DHEA-S (P/N: A10826) 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 Inhibin A Calibrators (P/N: A36098) Access Inhibin A QC (P/N: A36100) Access OV Monitor (P/N: 386357) Access Syphilis (P/N: C80411) Access Ultrasensitive hGH (P/N: 33580) UniCel DxI 800 Access Immunoassay System (P/N: 973100) Access Thyroglobulin Calibrators (P/N: 33865) Access Thyroglobulin Sample Diluent (P/N: 33866) Access Thyroglobulin (C71762) Access Ultrasensitive Insulin (P/N: 33410) Access Ultrasensitive Insulin Calibrators (P/N: 33415) Access Toxo IgM II QC (P/N: 34479) Access Toxo IgM II (P/N: 34470) Access Toxo IgM II Calibrators (P/N: 34475) Access Digoxin (P/N: 33710) Access Digoxin S0 Calibrator (P/N: 33716) Access Digoxin Calibrators (P/N: 33715) Access TPO Antibody Calibrators (P/N: A18227 FR MFG) Access TPO Antibody (P/N: A12985 MN and IE MFG) UniCel DxI 600 Access Immunoassay System (P/N: A30260) UniCel DxI 600 Access Immunoassay System w/ Dual Gantry (P/N: A71461) UniCel DxI 800 Access Immunoassay System w/ Dual Gantry (P/N: A71457) UniCel DxI 800 Access Immunoassay System w/ Spot B Gantry (P/N: A71456) UniCel DxI 800 Access Immunoassay System (P/N: 973100) UniCel DxI 600 Access Immunoassay System w/ Spot B Gantry (P/N: A71460) Access AccuTnI +3 for use on the UniCel DxI Immunoassay Systems. (P/N: A98264) Access AccuTnI +3 Calibrators for use on the UniCel DxI Immunoassay Systems.(P/N: A98265) Access Total T4 II C69047 Access Total T4 Calibrators (P/N: 33805) Access Total T4 (P/N: 33800) Access Total T4 II Calibrators C69048 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 Free T4 (P/N: C76421 MN and IE MFG) Access Free T4 Calibrators (P/N: 33885 MN MFG) Access CEA (P/N: 33200) Access Cortisol S0 Calibrator (P/N: 33606) Access Cortisol Calibrators (P/N:33605) Access Cortisol (P/N: 33600) Access Toxo IgM II (PN: 34470) Access hFSH (P/N: 33520 MN and IE MFG) Access hFSH Calibrators (P/N: 33525 MN and IE MFG) Access AccuTnI +3 for Use on the Access 2 Immunoassay System (P/N: A98143) Access 2 Immunoassay System (P/N: 81600N) Access AccuTnI +3 Calibrators for use on the Access 2 Immunoassay System (P/N A98144) Access CEA (P/N: 33200) Access CEA QC (P/N: 33029) Access CEA Diluent (P/N: 33206) Access CEA Calibrators (P/N: 33205) Access Myoglobin (P/N: 973243 MN and IE MFG) Access SHBG (P/N: A48617) Access SHBG (P/N: A48617 MN MFG) Access SHBG Calibrators Access SHBG Calibrators (P/N: A48618 FR MFG) Access SHBG QC (P/N: A48619 FR MFG) Access SHBG QC 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) Access sTFR (P/N: A32493) Access sTFR Calibrators (P/N: A32494) Access EPO (P/N: A16364) 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 p2PSA Calibrators (P/N: B03705) Access p2PSA (P/N: B03704) Access Myoglobin (P/N: 973243 MN and IE MFG) Access Myoglobin Calibrators (P/N: 973244 MN MFG) 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) Access hLH Calibrators (P/N: 33515 MN MFG) Access hLH (P/N: 33510 MN and IE MFG) Access Thyroid Uptake (P/N: 33810) Access Thyroid Uptake Calibrators (P/N: 33815) Access BNP II Access Thyroglobulin Calibrators (P/N: 33865) Access Thyroglobulin Sample Diluent (P/N: 33866) Access Thyroglobulin (P/N: 33860) ACCESS INHIBIN A (P/N: A36097) Access 2 Immunoassay System (Refurbished P/N: 386220) Access 2 Immunoassay system (P/N: 81600N) Access Free T3 (P/N: A13422 MN and IE MFG) IQ200 SPRINT 2008 TESTED (700-3325) Velocity Instrument, 2nd Gen SRM, Bringup and Test Stand Alone (B75503) Velocity Instrument, 2nd Gen SRM, Bringup and Test Computerless (B75502) iQ200 Elite Automated Urine Microscopy Analyzer (800-3052; 800-3934; 800-3052; 800-3934) iQ200 Sprint Automated Urine Microscopy Analyzer (800-3053; 800-3933; 800-3053; 800-3933) iQ200 Select Automated Urine Microscopy Analyzer (800-3935; 800-3051) UA Win10 Kit (C52900) DxU 850m Iris Automated Urine Microscopy Analyzer (PN C49513) DxU 840m Iris Automated Urine Microscopy Analyzer (PN C76947) 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) Access Total bhCG (5th IS) (P/N: A85264 MN and IE MFG) Access Total bhCG (5th IS) Calibrators (P/N: B11754 MN MFG) Access PCT (P/N: C53987) Access Ferritin Calibrators (P/N: 33025) Access Ferritin (P/N: 33020) Access OV Monitor Calibrators (P/N: 386358) Access OV Monitor (P/N: 386357) Access PCT (P/N: C53987) Access PCT Calibrators (P/N: C53986) Access BNP (P/N: 98200) Access BNP QC (P/N: 98201) Access BNP Calibrators (P/N: 98202) Access Testosterone (P/N: 33560) Access hsTnI Calibrator (P/N: C26909) Access Ostase Calibrators (P/N: 37305) Access Rubella IgG Access Intact PTH (P/N: A16972 MN and IE MFG) Access Unconjugated Estriol Calibrators (P/N: C22256) Access Unconjugated Estriol (P/N: 33570) Access Unconjugated Estriol (P/N: C22255) Access Thyroglobulin Antibody II (P/N: C86552) Access Thyroglobulin Antibody II Calibrators (P/N: A36920) Access hsTnI (P/N: B52699 MN and IE MFG) Access Toxo IgG Calibrators (P/N: A31589) Access Toxo IgG (P/N: A31588) Access Toxo IgG QC (P/N: A31590) Access Progesterone Calibrator S0 (P/N: 33556) Access Progesterone (P/N: 33550) Access Progesterone Calibrators (P/N: 33555) Access Progesterone II (P/N: C78020) Access Progesterone II Sample Diluent (P/N: C81798) Access Progesterone II Calibrators (P/N: C78021) Access Toxo IgG Access Ostase (P/N: 37300) 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) iQ Body Fluids Module Key Disc Set (800-3016) iQ Body Fluids Module Starter Kit (800-3704) Access Sensitive Estradiol Calibrator S0 (P/N: B97145) Access Sensitive Estradiol Calibrators (P/N: B84494) Access C-Peptide Calibrators (P/N: C31860) Access Syphilis Calibrators (P/N: C80412 MFG-BioRad) Access EPO (P/N: A16364) Access EPO Calibrators (P/N: A16365) Access Vitamin B12 (P/N: 33000 MN and IE MFG) Access Estradiol Calibrators (P/N: 33545) Access Estradiol Calibrators S0 (P/N: 33546) Access NT-proBNP (P/N: C71977) Access 25(OH) Vitamin D Total Calibrators for Use on the UniCel DxI Immunoassay System (P/N: A98857 MN MFG) Access 25(OH) Vitamin D Total for Use on the UniCel DxI Immunoassay System (P/N: A98856 MN and IE MFG) Access p2PSA QC (P/N: A56934) DxC 500i Clinical Analyzer, DxC 500i AU Chemistry Module, C63522 (JPN MFG) DxC 500i Clinical Analyzer, DxC 500i AU Chemistry Module, C63521 (JPN MFG) DxC 500i Clinical Analyzer, DxC 500i Access 2 Immunoassay Module, C13252 (Chaska MFG) Access GI Monitor (P/N: 387687) Access GI Monitor Calibrators (P/N: 387688) Access Free T4 (P/N: 33880 MN and IE MFG) Access Free T4 Calibrators (P/N: 33885 MN MFG) Access Folate (P/N: A98032 MN and IE MFG) Access Ultrasensitive hGH Calibrators (P/N: 33585)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
CHP	Radioimmunoassay, Estradiol	Clinical Chemistry	Class 1	862.1260	1992-07-14
CFT	Radioimmunoassay, Prolactin (Lactogen)	Clinical Chemistry	Class 1	862.1625	2008-08-14
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
CDZ	Radioimmunoassay, Testosterones And Dihydrotestosterone	Clinical Chemistry	Class 1	862.1680	2008-09-18
LFX	Enzyme Linked Immunoabsorbent Assay, Rubella	Microbiology	Class 2	866.3510	2012-09-21
MMI	Immunoassay Method, Troponin Subunit	Clinical Chemistry	Class 2	862.1215	2023-12-20
LIG	Radioassay, Intrinsic Factor Blocking Antibody	Clinical Chemistry	Class 2	862.1810	2024-05-14
LOK	Kit, Test, Alpha-Fetoprotein For Neural Tube Defects	Unknown	Class 3	N/A	2006-09-05
MOI	System, Test, Immunological, Antigen, Tumor	Immunology	Class 2	866.6010	2024-05-14
LTK	Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125)	Immunology	Class 2	866.6010	2024-05-14
JZO	System, Test, Thyroid Autoantibody	Immunology	Class 2	866.5870	2024-08-15
CIN	Electrophoretic Separation, Alkaline Phosphatase Isoenzymes	Clinical Chemistry	Class 2	862.1050	2024-04-25
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2012-09-21
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2008-09-18
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2008-09-18
LIG	Radioassay, Intrinsic Factor Blocking Antibody	Clinical Chemistry	Class 2	862.1810	2008-09-18
JIS	Calibrator, Primary	Clinical Chemistry	Class 2	862.1150	2024-09-17
CDP	Radioimmunoassay, Total Triiodothyronine	Clinical Chemistry	Class 2	862.1710	2024-09-17
JKC	Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate)	Clinical Chemistry	Class 1	862.1245	1992-07-14
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
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2009-10-28
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2009-10-28
LTK	Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125)	Immunology	Class 2	866.6010	2024-05-14
LIP	Enzyme Linked Immunoabsorption Assay, Treponema Pallidum	Microbiology	Class 2	866.3830	2024-09-24
CFL	Radioimmunoassay, Human Growth Hormone	Clinical Chemistry	Class 1	862.1370	1999-04-28
CEC	Radioimmunoassay, Free Thyroxine	Clinical Chemistry	Class 2	862.1695	2014-03-14
JLW	Radioimmunoassay, Thyroid-Stimulating Hormone	Clinical Chemistry	Class 2	862.1690	2014-03-14
MMI	Immunoassay Method, Troponin Subunit	Clinical Chemistry	Class 2	862.1215	2014-03-14
CHP	Radioimmunoassay, Estradiol	Clinical Chemistry	Class 1	862.1260	2014-03-14
CGR	Radioimmunoassay, Cortisol	Clinical Chemistry	Class 2	862.1205	2014-03-14
JJE	Analyzer, Chemistry (Photometric, Discrete), For Clinical Use	Clinical Chemistry	Class 1	862.2160	2014-03-14
MSW	System, Test, Thyroglobulin	Immunology	Class 2	866.6010	2023-11-22
CFP	Radioimmunoassay, Immunoreactive Insulin	Clinical Chemistry	Class 1	862.1405	1999-04-28
LGD	Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii	Microbiology	Class 2	866.3780	2012-09-21
KXT	Enzyme Immunoassay, Digoxin	Clinical Toxicology	Class 2	862.3320	2008-09-18
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
MMI	Immunoassay Method, Troponin Subunit	Clinical Chemistry	Class 2	862.1215	2014-03-14
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2014-03-14
JJE	Analyzer, Chemistry (Photometric, Discrete), For Clinical Use	Clinical Chemistry	Class 1	862.2160	2014-03-14
JIS	Calibrator, Primary	Clinical Chemistry	Class 2	862.1150	2012-09-21
KLI	Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine	Clinical Chemistry	Class 2	862.1700	2012-09-21
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
CEC	Radioimmunoassay, Free Thyroxine	Clinical Chemistry	Class 2	862.1695	2024-03-07
DHX	System, Test, Carcinoembryonic Antigen	Immunology	Class 2	866.6010	2023-11-22
CGR	Radioimmunoassay, Cortisol	Clinical Chemistry	Class 2	862.1205	2012-09-21
JIS	Calibrator, Primary	Clinical Chemistry	Class 2	862.1150	2012-09-21
LGD	Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii	Microbiology	Class 2	866.3780	2024-10-25
CGJ	Radioimmunoassay, Follicle-Stimulating Hormone	Clinical Chemistry	Class 1	862.1300	2007-06-07
MMI	Immunoassay Method, Troponin Subunit	Clinical Chemistry	Class 2	862.1215	2014-03-14
JJE	Analyzer, Chemistry (Photometric, Discrete), For Clinical Use	Clinical Chemistry	Class 1	862.2160	2014-03-14
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2014-03-14
DHX	System, Test, Carcinoembryonic Antigen	Immunology	Class 2	866.6010	2013-12-27
DDR	Myoglobin, Antigen, Antiserum, Control	Immunology	Class 2	866.5680	2023-09-22
CDZ	Radioimmunoassay, Testosterones And Dihydrotestosterone	Clinical Chemistry	Class 1	862.1680	2024-02-09
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2009-10-28
CDZ	Radioimmunoassay, Testosterones And Dihydrotestosterone	Clinical Chemistry	Class 1	862.1680	2009-10-28
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2009-10-28
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
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2008-09-18
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2008-09-18
DDG	Transferrin, Antigen, Antiserum, Control	Immunology	Class 2	866.5880	2008-09-18
GGT	Assay, Erythropoietin	Hematology	Class 2	864.7250	2024-04-25
PPM	General Purpose Reagent	Pathology	Class 1	864.4010	2006-07-24
OYA	P2psa	Unknown	Class 3	N/A	2013-11-21
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
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
CEP	Radioimmunoassay, Luteinizing Hormone	Clinical Chemistry	Class 1	862.1485	2002-04-24
CEE	Radioimmunoassay, Thyroxine-Binding Globulin	Clinical Chemistry	Class 2	862.1685	2012-09-21
NBC	Test, Natriuretic Peptide	Clinical Chemistry	Class 2	862.1117	2026-03-25
MSW	System, Test, Thyroglobulin	Immunology	Class 2	866.6010	2012-09-21
NDR	Enzyme Immunoassay, Inhibin-A	Clinical Chemistry	Class 1	862.1260	2007-04-24
JJE	Analyzer, Chemistry (Photometric, Discrete), For Clinical Use	Clinical Chemistry	Class 1	862.2160	2001-08-08
CDP	Radioimmunoassay, Total Triiodothyronine	Clinical Chemistry	Class 2	862.1710	1999-04-28
KQO	Automated Urinalysis System	Clinical Chemistry	Class 1	862.2900	2018-08-15
LKM	Counter, Urine Particle	Hematology	Class 2	864.5200	2014-07-16
KQO	Automated Urinalysis System	Clinical Chemistry	Class 1	862.2900	2014-07-16
CDD	Radioassay, Vitamin B12	Clinical Chemistry	Class 2	862.1810	2008-08-14
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
PTF	Assay To Measure Pct To Aid In The Risk Assessment Of Critically Ill Patients On Their First Day Of Icu Admission	Microbiology	Class 2	866.3215	2023-05-01
JMG	Radioimmunoassay (Two-Site Solid Phase), Ferritin	Immunology	Class 2	866.5340	2007-06-07
LTK	Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125)	Immunology	Class 2	866.6010	2012-09-24
PTF	Assay To Measure Pct To Aid In The Risk Assessment Of Critically Ill Patients On Their First Day Of Icu Admission	Microbiology	Class 2	866.3215	2020-01-08
NBC	Test, Natriuretic Peptide	Clinical Chemistry	Class 2	862.1117	2014-12-18
CDZ	Radioimmunoassay, Testosterones And Dihydrotestosterone	Clinical Chemistry	Class 1	862.1680	2023-01-18
JIS	Calibrator, Primary	Clinical Chemistry	Class 2	862.1150	2018-07-16
LFX	Enzyme Linked Immunoabsorbent Assay, Rubella	Microbiology	Class 2	866.3510	2025-11-21
CEW	Radioimmunoassay, Parathyroid Hormone	Clinical Chemistry	Class 2	862.1545	2024-03-07
CGI	Radioimmunoassay, Estriol	Clinical Chemistry	Class 1	862.1265	1992-07-14
JZO	System, Test, Thyroid Autoantibody	Immunology	Class 2	866.5870	2023-11-22
MMI	Immunoassay Method, Troponin Subunit	Clinical Chemistry	Class 2	862.1215	2018-07-16
LGD	Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii	Microbiology	Class 2	866.3780	2012-09-24
JLS	Radioimmunoassay, Progesterone	Clinical Chemistry	Class 1	862.1620	2012-09-21
JIS	Calibrator, Primary	Clinical Chemistry	Class 2	862.1150	2012-09-21
LGD	Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii	Microbiology	Class 2	866.3780	2025-04-14
JIS	Calibrator, Primary	Clinical Chemistry	Class 2	862.1150	2008-09-18
CIN	Electrophoretic Separation, Alkaline Phosphatase Isoenzymes	Clinical Chemistry	Class 2	862.1050	2008-09-18
GGK	Products, Red-Cell Lysing Products	Hematology	Class 1	864.8540	1977-12-14
GKL	Counter, Cell, Automated (Particle Counter)	Hematology	Class 2	864.5200	2019-04-09
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2018-02-02
GGT	Assay, Erythropoietin	Hematology	Class 2	864.7250	2008-08-14
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2008-08-14
CDD	Radioassay, Vitamin B12	Clinical Chemistry	Class 2	862.1810	2023-01-03
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2012-01-03
NBC	Test, Natriuretic Peptide	Clinical Chemistry	Class 2	862.1117	2024-04-17
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2015-01-22
MRG	System, Test, Vitamin D	Clinical Chemistry	Class 2	862.1825	2015-01-22
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2013-11-21
JJE	Analyzer, Chemistry (Photometric, Discrete), For Clinical Use	Clinical Chemistry	Class 1	862.2160	2025-03-07
CGR	Radioimmunoassay, Cortisol	Clinical Chemistry	Class 2	862.1205	2025-03-07
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2008-09-18
NIG	System, Test, Carbohydrate Antigen (Ca19-9), For Monitoring And Management Of Pancreatic Cancer	Immunology	Class 2	866.6010	2008-09-18
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
CGN	Acid, Folic, Radioimmunoassay	Clinical Chemistry	Class 2	862.1295	2023-08-31
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2012-09-21

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.

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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
K971921	Monobind	PROLACTIN (PRL) HORMONE MICROPLATE ELISA	1997-06-24
K882259	Diagnostic Chemicals, Ltd. (Usa)	DC-BILITROL CATALOGUE # SE-021, SE-022, SE-023	1988-07-21
K060322	Cliniqa Corporation	CLINIQA DRY QC CHEMISTRY CONTROL, LEVELS 1 AND 2, ASSAYED, CLINIQA DRY QC CHEMISTRY CONTROL, LEVEL 1 AND 2 UNASSAYED	2006-03-21
K081789	Siemens Healthcare Diagnostics, Inc.	DIMENSION CLINICAL CHEMISTRY SYSTEM ENZYME I CALIBRATOR	2008-09-10
K103836	Siemens Healthcare Diagnostics, Inc.	ENZYME II CALIBRATOR	2011-02-16

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0025-2025	Beckman Coulter, Inc.	1	Beckman Coulter Dxl 9000 Access Immunoassay Analyzer, REF #C11137. An in vitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination of various analyte concentrations found in human body fluids.
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.
Z-0025-2007	Abbott Diagnostic International, Ltd. Carr 2 Km 58.0 Cruce Davila	2	Architect FSH Calibrators (LN 6C24-01), for in vitro diagnostic use.
Z-0101-2021	Siemens Healthcare Diagnostics, Inc.	2	ADVIA Chemistry Systems-Fructosamine (FRUC)-For in vitro diagnostic use in the quantitative measurement of glycated protein (fructosamine) in human serum or plasma on the ADVIA Chemistry systems Siemens Material Number (SMN): 10361941

Similar Registrations

Registration Number	Establishment Name	Location
2432235	Siemens Healthcare Diagnostics Inc.	Tarrytown, NY, US
3003741796	DIRUI INDUSTRIAL CO., LTD.	CHANGCHUN Jilin, CN
3009335633	DiaSource ImmunoAssays, SA	Louvain-La-Neuve Brabant Wallon, BE
8020888	Siemens Healthcare Diagnostics Manufacturing Ltd.	SWORDS Dublin, IE
8023018	Immunotech SAS, a Beckman Coulter company	MARSEILLE, CEDEX 9 Bouches-du-Rhone, FR

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2122870. Last updated year: 2026. Please use registration number 2122870 when referencing this establishment in official correspondence.