FDA.reportPublic FDA data

Beckman-Coulter

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
10178351017835BECKMAN COULTER, INC.1N2026-01-01740 WEST 83RD ST. HIALEAH FL US 33014
10619323000203293BECKMAN COULTER, INC.1N2026-01-0111800 SW 147TH AVE. Miami FL US 33196
20500102050010BECKMAN COULTER, INC.1N2026-01-012470 Faraday Ave CARLSBAD CA US 92010
20500122050012BECKMAN COULTER, INC.1Y2026-01-01250 S Kraemer Blvd BREA CA US 92821
21228702122870BECKMAN COULTER, INC.1Y2026-01-011000 LAKE HAZELTINE DR. CHASKA MN US 55318
29190162919016Beckman Coulter, Inc.1N2026-01-011584 Enterprise Blvd West Sacramento CA US 95691
30041983943004198394BECKMAN COULTER, INC.1N2026-01-015350 Lakeview Parkway South Dr INDIANAPOLIS IN US 46268
30074481243007448124Beckman Coulter, Inc1N2026-01-015355 W. 76th Street Indianapolis IN US 46268
30086297853008629785Beckman Coulter, Inc.1N2026-01-012295 Progress Dr. Suite C Hebron KY US 41048
30213948623021394862Beckman Coulter Biomedical GmbH1N2026-01-01Kuehler Weg 1 Baierbrunn Bavaria DE 82065
10348861034886BECKMAN COULTER, INC.1N2020-04-257381 EMPIRE DR. FLORENCE KY US 41042
30032447103003244710Beckman Coulter Laboratory Systems (Suzhou) Co., Ltd.1N2020-04-25No. 181 West Su Hong Road Suzhou Industrial Park Suzhou Jiangsu CN 215021
30106868563010686856Beckman Coulter India Private Limited1N2020-04-25Bangalore Development Center #50-B 2nd Phase, Near TVS Cross Peenya Industrial Area Bengaluru Karnataka IN 560058
30135136073013513607Beckman Coulter GmbH1N2020-04-25Frauenberg Str. 31 Marburg Hessen DE D-35041

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
52651916923527P980041ACCESS AFP IMMUNOASSAY SYSTEMLOK1999-02-08
52651983974987P970038TANDEM-R FREE PSA IMMUNORADIOMETRIC ASSAY/TANDEM-MP FREE PSA IMMUNOENZYMETRIC ASSAYMTG1998-03-10
1805691390672708P870049MICROSCAN RAPID PANELSLON1988-02-24
52651392937718P850048TANDEM-R PSA IMMUNORADIOMETRIC ASSAYMTF1986-02-25
52651720188432P090026ACCESS HYBRITECH P2PSA ON THE ACCESS IMMUNOASSAY SYSTEMSOYA2012-06-14
52651259848934K994278ACCESS OSTASE IMMUNOENZYMETRIC ASSAYCIN2000-03-28
52651776628652K994277ACCESS OSTASE QCJJX2000-01-14
52651423505104K994200ACCESS HYBRITECH PSA QC, MODEL 37209JJX2000-01-18
52591671570126K994168SYNCHRON LX SYSTEMS PREALBUMIN CALIBRATORJIS2000-02-03
52591225792899K993954SYNCHRON SYSTEMS DAT MULTI-DRUG LOW AND HIGH URINE CALIBRATORSDKB2000-01-11
52591311222435K993547BECKMAN COULTER IMMAGE IMMUNOCHEMISTRY SYSTEM LOW CONCENTRATION IMMUNOGLOBULIN M (IGMLC) REAGENT, BECKMAN COULTER CEREBCFN2000-02-01
52591605584423K993473SYNCHRON SYSTEMS DRUG CALIBRATOR 2DLJ1999-11-26
52651691020928K993210ACCESS HYBRITECH FREE PSA QC, MODEL 37219JJX2000-01-05
1805691991932618K993102DRIED GRAM-POSITIVE MIC/COMBO PANELSLTT1999-12-02
52591981979228K993065ACON COMBO PREGNANCYJHI1999-10-08
52701981979228K993065ACON COMBO PREGNANCYJHI1999-10-08
52591086352708K993023SYNCHRON SYSTEMS OP 300 LOW AND HIGH URINE CONTROLSJJY1999-11-26
52591503746692K993022SYNCHRON SYSTEMS OP 300 LOW AND HIGH URINE CALIBRATORSDLJ1999-11-09
52591979860894K992511ABX PENTRA 60 HEMATOLOGY ANALYZERGKZ1999-10-15
52701979860894K992511ABX PENTRA 60 HEMATOLOGY ANALYZERGKZ1999-10-15
52591490859743K990352COULTER AC T DIFF 2 ANALYZERGKZ1999-04-01
52701490859743K990352COULTER AC T DIFF 2 ANALYZERGKZ1999-04-01
52591682024224K990327RETICONE SYSTEM FOR EPICS XL FLOW CYTOMETRY SYSTEMSGKZ1999-04-26
52671682024224K990327RETICONE SYSTEM FOR EPICS XL FLOW CYTOMETRY SYSTEMSGKZ1999-04-26
52701682024224K990327RETICONE SYSTEM FOR EPICS XL FLOW CYTOMETRY SYSTEMSGKZ1999-04-26
52591530491837K990172TETRAONE SYSTEM FOR EPICS XL FLOW CYTOMETRY SYSTEMS WITH CYTO-STAT TETRACHROME CD45-FITC/CD4-RD1/CD8-ECD/CD3-PC5 MONOCLAGKZ1999-04-13
52701530491837K990172TETRAONE SYSTEM FOR EPICS XL FLOW CYTOMETRY SYSTEMS WITH CYTO-STAT TETRACHROME CD45-FITC/CD4-RD1/CD8-ECD/CD3-PC5 MONOCLAGKZ1999-04-13
52591495836614K984402SYNCHRON SYSTEMS AMMONIA (AMM) REAGENTJIF1999-01-29
52591466482381K984216IMMUNO-TROL CONTROL CELLSJPK1999-03-16
52701466482381K984216IMMUNO-TROL CONTROL CELLSJPK1999-03-16
52591522269577K984152SYNCHRON SYSTEMS OPIATES 2000 NG (OP2) REAGENTDJG1999-01-29
52591484478185K983709SYNCHRON SYSTEMS DAT LOW AND HIGH URINE CONTROLS 1DIF1998-10-28
52591808135442K983640SYNCHRON SYSTEMS LIPID CALIBRATORJIS1998-12-21
52591858341396K983386BIOSTREP A-DIRECT STREP A ANTIGEN TESTGTY1998-11-25
52701858341396K983386BIOSTREP A-DIRECT STREP A ANTIGEN TESTGTY1998-11-25
52591433817203K983340IMMAGE IMMUNOCHEMISTRY SYSTEM FERRITIN (FER)REAGENT, IMMAGE IMMUNOCHEMISTRY SYSTEM FERRITIN CALIBRATORDBF1998-12-14
52591495720686K982935SYNCHRON SYSTEMS DIGOXIN (DIGN) REAGENT, SYNCHRON SYSTEMS DRUG CALIBRATORKXT1998-10-14
52651075537151K982250ACCESS FREE T4 REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZERCEC1998-07-14
52591814612626K982224VIGIL PROTEIN CONTROLJJY1998-07-09
52591836513090K982172CYTO-STAT CD3-FITC/CD56-RDI MONOCLONAL ANTIBODY REAGENT WITH CYTO-STAT/COULTER CLONE MSIGGI-RD1/MSIGGI-FITC ISOTYPIC COLGKZ1998-09-24
52701836513090K982172CYTO-STAT CD3-FITC/CD56-RDI MONOCLONAL ANTIBODY REAGENT WITH CYTO-STAT/COULTER CLONE MSIGGI-RD1/MSIGGI-FITC ISOTYPIC COLGKZ1998-09-24
52591888366708K982167CYTO-STAT TRICHROME CD45-FITC/CD19-RD1/CD3-PC5 MONOCLONAL ANTIBODY REAGENT WITH CYTO-STAT TRICHROME CD45-FITC/MSIGG1-RD1GKZ1998-11-09
52701888366708K982167CYTO-STAT TRICHROME CD45-FITC/CD19-RD1/CD3-PC5 MONOCLONAL ANTIBODY REAGENT WITH CYTO-STAT TRICHROME CD45-FITC/MSIGG1-RD1GKZ1998-11-09
52591145376821K982166CYTO-STAT TRICHROME CD45-FITC/CD56-RD1/CD3-PC5 MONOCLONAL ANTIBODY REAGENT WITH CYTO-STAT TRICHROME CD45-FITC/MSIGG1-RD1GKZ1998-11-05
52701145376821K982166CYTO-STAT TRICHROME CD45-FITC/CD56-RD1/CD3-PC5 MONOCLONAL ANTIBODY REAGENT WITH CYTO-STAT TRICHROME CD45-FITC/MSIGG1-RD1GKZ1998-11-05
52591265287796K982022VIGIL HEMOGLOBIN (HBALC) CONTROLSJJX1998-07-06
52651417711427K981985ACCESS CEA REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER MODEL 33200, 33205, 33206 & 33209DHX1998-09-24
52651979000901K981864ACCESS AFP QC ON THE ACCESS IMMUNOASSAY ANALYZER, MODEL NUMBER 33219JJX1998-06-12
52591781940815K981638IMMAGE IMMUNOCHEMISTRY SYSTEM C-REACTIVE PROTEIN (CRP) REAGENTDCK1998-06-12
1805691433276525K981199MICROSCAN DRIED GRAM NEGATIVE MIC/COMBO PANELS , ESBL SCREENLRG1998-11-18
52591619463249K974620AMMONIA-INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY (DST)JIF1998-01-02
52592066571597K974564IMMAGE IMMUNOCHEMISTRY SYSTEM ALPHA-2-MACROGLOBULIN REAGENTDEB1998-02-17
52591822271747K974452VIGIL LIPID CONTROLJJY1997-12-17
52591819319978K974110IMMAGE IMMUNOCHEMISTRY SYSTEM ANTITHROMBIN III (AT3) REAGENTJBQ1997-12-24
52591439956095K974050SYNCHRON SYSTEMS C-REACTIVE PROTEIN (CRP) REAGENTDCK1997-11-24
52651131175901K973966ACCESS TOTAL T3 REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZERCDP1997-10-31
52591839400454K973932BECKMAN CALIBRATOR 2 (CAL2)JIX1997-12-15
52591754844327K973928BECKMAN URINE PROTEIN CALIBRATOR (UCAL)JIX1997-12-01
52591386377706K973634COULTER AC.T DIFF ANALYZERGKZ1997-10-29
52701386377706K973634COULTER AC.T DIFF ANALYZERGKZ1997-10-29
52591194207491K973069SYNCHRON SYSTEMS METHADONE REAGENTDJR1997-09-22
52591808719908K972819VIGIL TDM CONTROLSDIF1997-08-13
1805691674821166K972799DRIED GRAM-POSITIVE MIC/COMBO PANELSLTT1997-10-10
1805691426863075K972688MICROSCAN DRIED GRAM POSITIVE MIC/COMBO PANELS LEVOFLOXACINJWY1997-09-08
52591494398348K971958SYNCHRON LX SYSTEMS TRANSFERRIN (TRFN) REAGENTDDG1997-08-20
52591902027938K971534SYNCHRON SYUSTEMS DAT DRUG FREE URINE CONTROLDIF1997-05-21
1805691608079266K971376DRIED GRAM-NEGATIVE MIC/COMBO PANELSJWY1997-05-30
52592057142392K971333SYNCHRON SYSTEMS ALKALINE PHOSPHATASE REAGENT, CHOLINESTERASE REAGENT, GAMMA-GLUTAMYL TRANSFERASE REAGENT, LACTATE DEHYDJIX1997-05-23
52591227027092K971287SYNCHRON SYSTEMS DRUG CALIBRATION 3 PLUSDKB1997-05-08
52591055119303K971283SYNCHRON SYSTEMS CAL 5 PLUSJIX1997-06-03
52591350660173K971210SYNCHRON SYSTEMS 10 NG/ML & 40 NG/ML THC URINE CONTROLSLAS1997-04-17
52591092506688K970919SYNCHRON CX SYSTEMS URIC ACID (URIC) REAGENTKNK1997-05-21
1805691309237940K970676DRIED GRAM-NEGATIVE MIC/COMBO PANELSJWY1997-05-02
52591604711202K970314SYNCHRON LX SYSTEMS APOLIPOPROTEIN (APOA AND APOB) REAGENTSMSJ1997-04-21
52591521976446K965240SYNCHRON LX 20 CLINICAL CHEMISTRY SYSTEM, SYNCHRON LX ALBUMIN REAGENT, SYNCHRON LX CREATININE PICRIC REAGENT, SYNCHRON LJJE1997-03-10
52592059504877K965108SYNCHRON LX SYSTEMS IMMUNOGLOBULIN G/A/M REAGENTDEW1997-03-06
52591029261031K965035IMMAGE IMMUNOCHEMISTRY SYSTEM MICROALBUMIN (MA) REAGENTJIQ1997-04-17
52591155191421K965033IMMAGE IMMUNOCHEMISTRY SYSTEM ALPHA-1-MICROGLOBULIN (AI) REAGENTMGA1997-04-21
52591918115472K964988COULTER AC.T SERIES ANALYZERGKZ1997-03-06
52701918115472K964988COULTER AC.T SERIES ANALYZERGKZ1997-03-06
52591363872757K964843IMMAGE IMMUNOCHEMISTRY SYSTEM PROPERDIN FACTOR B (PFB) REAGENTJZH1997-03-06
52591799020823K964842IMMAGE IMMUNOCHEMISTRY SYSTEM COMPLEMENTC3 (C3) AND COMPLEMENTC4 (C4) REAGENTCZW1997-06-11
52592005694565K964781IMMAGE IMMUNOCHEMISTRY SYSTEM PREALBUMIN (PAB) REAGENTDDS1997-05-09
52591089204213K964766IMMAGE IMMUNOCHEMISTRY SYSTEM ALPHA-1-ANTITRYPSIN (AAT)DEM1997-04-25
52591477197445K964762IMMAGE IMMUNOCHEMISTRY SYSTEM CERULOPLASMIN (CER) REAGENTDDB1997-04-25
52591063501015K964695IMMAGE IMMUNOCHEMISTRY SYSTEM ALBUMIN (ALB) REAGENTDCF1997-04-29
52591958693108K964618CYTO-STAT TRICHROME CD8-FITC/CD4-RDI/CD3-PC5 MONOCLONAL ANTIBODY REAGENT WITH CYTO-STAT TRICHROME MSIGGI-FITC/MSIGGI-RD1GKZ1996-12-23
52701958693108K964618CYTO-STAT TRICHROME CD8-FITC/CD4-RDI/CD3-PC5 MONOCLONAL ANTIBODY REAGENT WITH CYTO-STAT TRICHROME MSIGGI-FITC/MSIGGI-RD1GKZ1996-12-23
52591038592174K964260IMMAGE IMMUNOCHEMISTRY SYSTEM KAPPA LIGHT CHAIN (KAP) REAGENT IMMAGE IMMUNOCHEMISTRY SYSTEM LAMDA LIGHT CHAIN (LAM) REAGDFH1997-02-10
52591022587960K964257IMMAGE IMMUNOCHEMISTRY SYSTEM ALPHA-1-ACID GLYCOPROTEIN (AAG) REAGENTLKL1997-03-24
52591035474500K964010IMMAGE IMMUNOCHEMISTRY SYSTEM APOLIPOPROTEIN A-1 REAGENT (APA)/ IMMAGE IMMUNOCHEMISTRY SYSTEM APOLIPOPROTEIN B REAGENTMSJ1997-02-10
52591714818281K963976IMMUNOCHEMISTRY SYS URINE TRANSFERRIN REAGENTDDG1997-03-19
52591052501038K963974IMAGE-IMMUNOCHEMISTRY SYSTEM URINE IMMUNOGLOBULINDEW1997-03-06
52591004116326K963868IMMAGE IMMUNOCHEMISTRY SYSTEM IMMUNOGLOBULIN G (IGG), A (IGA) AND M (IGM)DEW1997-02-10
52591559883437K963427IMMAGE IMMUNOCHEMISTRY SYSTEM TRANSFERRIN (TRF) REAGENTDDG1996-10-07
52591161876604K963286IMMAGE IMMUNOCHEMISTRY SYSTEM HAPTOGLOBIN (HPT) REAGENTDAD1996-10-07
52591289125070K963263TETRAONE SYSTEM FOR EPICS XL FLOW CYTOMETRY SYSTEMS AND CYTO-STAT TERTRACHROME CD45-FITC/CD4-RDI/CD8-ECD/CD3-PC5GKZ1997-01-22
52671289125070K963263TETRAONE SYSTEM FOR EPICS XL FLOW CYTOMETRY SYSTEMS AND CYTO-STAT TERTRACHROME CD45-FITC/CD4-RDI/CD8-ECD/CD3-PC5GKZ1997-01-22
52701289125070K963263TETRAONE SYSTEM FOR EPICS XL FLOW CYTOMETRY SYSTEMS AND CYTO-STAT TERTRACHROME CD45-FITC/CD4-RDI/CD8-ECD/CD3-PC5GKZ1997-01-22
52591096102389K963048IMMAGE SYSTEM RHEUMATOID FACTOR (RF) REAGENTDHR1996-11-04
52671482109484K962988COULTER GEN-S SYSTEMGKL1996-10-30
52591946880680K962768CYTO-STAT TRICHROME CD45-FITC/CD4-RDI/CD3-PC5 MONOCLONAL ANITBODY REAGENT W/ISOTYPIC CONTROLGKZ1997-01-06
52701946880680K962768CYTO-STAT TRICHROME CD45-FITC/CD4-RDI/CD3-PC5 MONOCLONAL ANITBODY REAGENT W/ISOTYPIC CONTROLGKZ1997-01-06
52591093572004K962305CYTO-STAT TRICHROME CD45-FITC/CD8-RD1/CD3-PC5 MONOCLONAL ANTIBODY REAGENT IWTH ISOTYPIC CONTROLGKZ1997-01-06
52701093572004K962305CYTO-STAT TRICHROME CD45-FITC/CD8-RD1/CD3-PC5 MONOCLONAL ANTIBODY REAGENT IWTH ISOTYPIC CONTROLGKZ1997-01-06
52591082688856K962294IMMAGE IMMUNOCHEMISTRY SYSTEMJQX1996-08-21
2290001082688856K962294IMMAGE IMMUNOCHEMISTRY SYSTEMJQX1996-08-21
1805691003229200K962150DRIED GRAM-NEGATIVE AND GRAM-POSITIVE MIC/COMBO PANELSLTT1996-08-16
52701430315781K961024BIOSIGN MONO-PLUS WB,BIOSIGN MONO WB,MONO-PLUS WB,ACCUSIGN MONO WBKTN1997-02-04
52592072597944K960485SYNCHRON SYSTEMS IRON (FE)/TOTAL IRON BINDING CAPACITY REAGENTSJMO1996-05-10
1805691190187767K955910DRIED GRAM-NEGATIVE MIC/COMBO PANELSJWY1996-02-23
52651469047404K955769ACCESS PROGESTERONE ASSAYJLS1996-02-05
52591260774089K955677SYNCHRON SYSTEMS CANNABINOID 20 NG REAGENTLDJ1996-04-03
52571803059983K955676SYNCHRON SYSTEMS METHAQUALONE REAGENTKXS1996-03-04
52591803059983K955676SYNCHRON SYSTEMS METHAQUALONE REAGENTKXS1996-03-04
52591949411972K955675SYNCHRON SYSTEMS PROPOXYPHENE REAGENTJXN1996-02-09
52591475017749K955644SYNCHRON SYSTEMS CARBAMAZEPINE TEST SYSTEMKLT1996-02-16
52651054552816K955436ACCESS VITAMIN B12 ASSAY (MODIFICATION)CDD1996-01-24
52651945104144K955434ACCESS FOLATE ASSAY (MODIFICATION)CGN1996-01-29
52591432696901K9550164C PLUS COULTER CELL CONTROLJPK1996-01-30

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
GKZ942024-07-05
JWY412021-05-18
LTT372025-08-20
LRG272011-08-04
JPK252009-02-03
JIX92011-05-25
MMI82023-12-18
JIT82015-02-26
JJX72011-11-04
JJY72001-03-05
DDG52024-07-03
JHI52002-12-20
NBC42026-03-24
LGD42025-03-28
CDZ42024-02-08
CDD42022-12-23
JLW42022-11-10
OYE42017-06-23
LCP42014-07-14
KQO42011-03-23
JIS42001-05-10
DEW41997-03-06
CGR32025-03-05
JNL32024-07-03
MSW32024-06-28
DHX32023-09-22
CGN32023-08-23
LON32020-08-30
PWD32019-03-21
CFR32014-04-17
LKM32010-02-05
KHE32008-06-25
JJW32007-12-21
NQD32007-06-21
CGX32007-06-01
CDT32007-03-23
DCK32001-04-05
DIF31998-10-28
LDJ31996-04-03
LFX22025-11-17

PMA#

Access Hybritech p2PSA Reagents on the Access Immunoassay Systems

2022-12-16

BECKMAN COULTER, INC.1000 Lake Hazeltine Dr.chaska, MN 55318 PMA NumberP090026 Supplement NumberS031 Date Received04/19/2021 Decision Date12/16/2022 Product Code OYA  Advisory Committee Immunology Supplement Typereal-time Process Supplement Reason Change De...

Access Hybritech Free PSA Reagents on the Access Immunoassay Systems

2022-12-16

BECKMAN COULTER, INC.250 South Kraemer Blvd M/sw-110brea, CA 92822 PMA NumberP970038 Supplement NumberS045 Date Received04/19/2021 Decision Date12/16/2022 Product Code MTG  Advisory Committee Immunology Supplement Typereal-time Process Supplement Reason Cha...

Access Hybritech PSA Reagents on the Access Immunoassay Systems

2022-03-03

BECKMAN COULTER, INC.250 South Kraemer Blvd M/sw-110brea, CA 92822 PMA NumberP850048 Supplement NumberS058 Date Received02/04/2022 Decision Date03/03/2022 Product Code MTF  Advisory Committee Immunology Supplement Type30-day Notice Supplement Reason Process...

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PMN#

200 records. Showing 1-40. Next

GUDID#

iChem Velocity - "2.5 iChem Velocity Instrument Computerless Bring Up and Test; 800-7720 Back-Integrated Velocity (NA)2.5 iChem Velocity Instrument Computerless Bring Up and Test; 800-3530 Back Integrated Velocity Computerless System Ready (NA)""2.5 iChem Velocity Instrument Computerless Bring Up and Test; 800-7106 COMPUTERLESS VELOCITY""""2.5 iChem Velocity Instrument Computerless Bring Up and Test;800-7190 IRICELL 1500 (NA)""""2.5 iChem Velocity Instrument Computerless Bring Up and Test;800-3049 iRICELL 2000 Pro (NA)""2.5 iChem Velocity Instrument Computerless Bring Up and Test; 800-7714 iRICELL 2000 Plus (NA)""2.5 iChem Velocity Instrument Computerless Bring Up and Test; 800-7713 iRICELL 3000 Plus (NA)""""2.5 iChem Velocity Instrument Computerless Bring Up and Test; 800-3079 iRICELL 3000 Pro (NA) w load/unload""""2.5 iChem Velocity Instrument Computerless Bring Up and Test; 800-3048 iRICELL 3000 Pro (NA)""""2.5 iChem Velocity Instrument Computerless Bring Up and Test; 800-3080 iRICELL 3000 PRO w/ Load/Unload""""2.5 iChem Velocity Instrument Computerless Bring Up and Test; 800-3050 iRICELL 1000 Pro (NA)"""

BECKMAN COULTER IRELAND INC.

2016-09-07

80 records. Showing 1-40. Next