BECKMAN COULTER, INC

FDA Filings

This page includes the latest FDA filings for BECKMAN COULTER, INC. Currently, you will find the latest 25 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

Latest Premarket Notifications

ManufacturerDevice NameDate
Beckman Coulter, Inc
MicroScan Dried Gram Negative MIC/Combo Panels With Ciprofloxacin (Cp) (0.004 - 8µg/mL)2020-03-18
Beckman Coulter, Inc.
MicroScan Dried Gram-Negative MIC/Combo Panels With Levofloxacin (Lvx) (0.008-16ug/mL)2020-03-03
Beckman Coulter, Inc.
Access PCT, Access PCT Calibrators2019-11-26
Beckman Coulter, Inc.
MicroScan Dried Gram Negative MIC/Combo Panels With Meropenem (Mer) (0.004-32ug/mL)2019-11-14
Beckman Coulter Biomedical GmbH
DxA 5000, DxI 800 Access Immunoassay System, Access Ferritin, Access Folate, Access TSH (3rd IS), Access Vitamin B122019-10-04
Beckman Coulter
Cytomics FC 500 Series (MPL Or MCL) Flow Cytometer2019-09-06
Beckman Coulter, Inc.
MicroScan Dried Gram Negative MIC/Combo Panels With Eravacycline (ERV) (0.016-32 Ug/mL)2019-04-18
Beckman Coulter
ClearLLab 10C Panels (B, T, M1, M2), Navios Flow Cytometer, Navios EX Flow Cytometer2019-03-21
Beckman Coulter
Unicel DxH 800 Cellular Analysis System With Early Sepsis Indicator Application2019-03-18
Beckman Coulter
DxH 520 Hematology Instrument2019-03-01
Beckman Coulter, Inc.
MicroScan Dried Gram Negative MIC/Combo Panels With Meropenem/Vaborbactam (0.03/8-64/8ug/mL)2019-02-12
Beckman Coulter Ireland Inc.
HbA1c Advanced2019-01-16
Beckman Coulter, Inc.
Access HsTnl2018-06-14
Beckman Coulter, Inc.
Access Hs Tnl2018-06-12
Beckman Coulter, Inc.
MicroScan Dried Gram Negative MIC/Combo Panels With Ceftazidime/Avibactam (0.25/4 - 64/4 Ug/mL)2017-12-15
Beckman Coulter Inc.
MicroScan Dried Gram-Negative MIC/Combo Panels With Ciprofloxacin-S (0.004 – 8 µg/mL)2017-12-07
Beckman Coulter, Inc
MicroScan Dried Gram Negative MIC/Combo Panels With Ceftolozane/tazobactam (0.25/4 - 16/4 Ug/mL)2017-12-01
Beckman Coulter, Inc.
Access AMH2017-11-13
BECKMAN COULTER
Navios EX Flow Cytometer, 6 Color/2 Laser, Navios EX Flow Cytometer, 8 Color/2 Laser, Navios EX Flow Cytometer, 10 Color/3 Laser2017-06-23
BECKMAN COULTER, INC.
MicroScan Dried Gram-Negative MIC/Combo Panels With Imipenem (0.25 - 8 Ug/mL)2017-03-21
BECKMAN COULTER INC.
DxC 700 AU Clinical Chemistry Analyzer, AU IgG Reagent2017-01-09
BECKMAN COULTER IRELAND INC.
Ceruloplasmin2017-01-09
BECKMAN COULTER INC.
ISE Reagent, Glucose, CRP Latex, DxC 700 AU Clinical Chemistry Analyzer2016-12-16
BECKMAN COULTER, INC.
UniCel DxH SlideMaker Stainer Coulter Cellular Analysis System2016-11-29
BECKMAN COULTER, INC.
Access TSH (3RD IS) Assay And Access TSH (3RD IS) Calibrators On The Access Immunoassay Systems2016-08-18
Beckman Coulter Ireland Inc.
Beta-2-Microglobulin2016-06-07
BECKMAN COULTER, INC.
MicroScan Dried Gram Positive MIC/Combo Panels - Vancomycin (0.25-64 Ug/mL)2015-09-16
BECKMAN COULTER, INC.
AQUIOS CL FLOW CYTOMETER, AQUIOS TETRA-1 PANEL,AQUIOS TETRA-2+PANEL, AQUIOS IMMUNO-TROL, AQUIOS IMMUNO-TROL LOW, AQUIOS2015-04-10
BECKMAN COULTER, INC.
UniCel DxC SYNCHRON System HDL Cholesterol Reagent(HDL),Unicel DxC SYNCHRON System HDL Calibrator2015-02-26
BECKMAN COULTER, INC.
Access 25(OH) Vitamin D Total For Use On The Access 2 Immuno. Syst., Access 25(OH) Vitamin D Total Calibrators For Use On The Access 2 Immuno. Syst2014-12-22

Latest Premarket Applications

PMAManufacturerDevice NameDate
BECKMAN COULTER, INC.
Access AFP Reagents on the Access Immunoassay Systems2020-03-17
BECKMAN COULTER, INC.
Access Hybritech p2PSA Reagents on the Access Immunoassay Systems2020-03-17
BECKMAN COULTER, INC.
Access Hybritech PSA Reagents on the Access Immunoassay Systems2020-03-17
BECKMAN COULTER, INC.
Access Hybritech Free PSA Reagents on the Access Immunoassay Systems2020-03-17
BECKMAN COULTER, INC.
Access Hybritech PSA Reagents on the Access Immunoassay Systems2019-08-09
BECKMAN COULTER, INC.
Access AFP Reagents on the Access Immunoassay Systems2019-08-09
BECKMAN COULTER, INC.
Access Hybritech p2PSA Reagents on the Access Immunoassay Systems2019-08-09
BECKMAN COULTER, INC.
Access Hybritech Free PSA Reagents on the Access Immunoassay Systems2019-08-09
BECKMAN COULTER, INC.
Access Hybritech Free PSA Reagents on the Access Immunoassay Systems2019-07-31
BECKMAN COULTER, INC.
Access AFP Reagents on the Access Immunoassay Systems2019-07-31
BECKMAN COULTER, INC.
Access Hybritech PSA Reagents on the Access Immunoassay Systems2019-07-31
BECKMAN COULTER, INC.
Access Hybritech p2PSA Reagents on the Access Immunoassay Systems2019-07-31
BECKMAN COULTER, INC.
Access Hybritech p2PSA Reagent Pack2019-01-09
BECKMAN COULTER, INC.
Access Hybritech Free PSA Reagents on the Access Immunoassay Systems2018-12-21
BECKMAN COULTER, INC.
Acess AFP Reagents on the Access Immunoassay Systems2018-12-21
BECKMAN COULTER, INC.
Access Hybritech p2PSA Reagents on the Access Immunoassay Systems2018-12-21
BECKMAN COULTER, INC.
Access Hybritech PSA Reagents on the Access Immunoassay Systems2018-12-21
BECKMAN COULTER, INC.
Access AFP Reagents on the Access Immunoassay Systems2018-09-12
BECKMAN COULTER, INC.
Access Hybritech PSA Assay2017-10-24
BECKMAN COULTER, INC.
Access Hybritech free PSA Reagents/Calibrator Kit Immunoassay Systems2017-10-24
BECKMAN COULTER, INC.
Access Hybritech p2PSA Reagents on the Access Immunoassay System2017-10-24
BECKMAN COULTER, INC.
Access AFP Immunoassay2017-10-24
BECKMAN COULTER, INC.
Access Hybritech Free PSA Reagents on the Access Immunoassay Systems2017-07-07
BECKMAN COULTER, INC.
Access Hybritech p2PSA Reagents on the Access Immunoassay Systems2017-07-07
BECKMAN COULTER, INC.
Access Hybritech PSA Reagents on the Access Immunoassy Systems2017-07-07
BECKMAN COULTER, INC.
Access AFP Reagents on the Access Immunoassy Systems2017-07-07
BECKMAN COULTER, INC.
Access Hybritech Free PSA Reagents on the Access Immunoassay Systems2017-06-16
BECKMAN COULTER, INC.
Access AFP Reagents on the Access Immunoassay Systems2017-06-16
BECKMAN COULTER, INC.
Access Hybritech PSA Reagents on the Access Immunoassay Systems2017-06-16
BECKMAN COULTER, INC.
Access Hybritech p2PSA Reagents on the Access Immunoassay Systems2017-06-16

Latest De Novo Filings

De NovoManufacturerDevice NameDate
Beckman Coulter
ClearLLab T1, ClearLLab T2, ClearLLab B1, ClearLLab B2, ClearLLab M2017-06-29

GUDID Registrations

Device GUDID
Device Name
ManufacturerDate
UA Win10 Kit
BECKMAN COULTER IRELAND INC.2020-03-30
Access Hybritech p2PSA Calibrators
Beckman Coulter, Inc.2020-02-06
Access Hybritech p2PSA
Beckman Coulter, Inc.2020-02-06
Access Hybritech p2PSA QC
Beckman Coulter, Inc.2020-02-06
Access Hybritech free PSA QC
Beckman Coulter, Inc.2020-02-06
Access Hyritech free PSA Calibrators
Beckman Coulter, Inc.2020-02-06
Access Hybritech free PSA
Beckman Coulter, Inc.2020-02-06
Access Hybritech PSA QC
Beckman Coulter, Inc.2020-02-06
Access Hybritech PSA Sample Diluent
Beckman Coulter, Inc.2020-02-06
Access Hybritech PSA Calibrators
Beckman Coulter, Inc.2020-02-06
Access Hybritech PSA
Beckman Coulter, Inc.2020-02-06
MicroScan
Beckman Coulter, Inc.2019-12-26
MicroScan
Beckman Coulter, Inc.2019-12-26
MicroScan
Beckman Coulter, Inc.2019-12-26
DxH 520
BECKMAN COULTER IRELAND INC.2019-12-23
DxH 900 Hematology System
Beckman Coulter, Inc.2019-12-23
UniCel DxH
Beckman Coulter, Inc.2019-12-23
UniCel DxH
Beckman Coulter, Inc.2019-12-23
COULTER LH
Beckman Coulter, Inc.2019-12-23
COULTER LH
Beckman Coulter, Inc.2019-12-23
COULTER HmX
Beckman Coulter, Inc.2019-12-23
COULTER LH
Beckman Coulter, Inc.2019-12-23
COULTER LH
Beckman Coulter, Inc.2019-12-23
COULTER AcT
Beckman Coulter, Inc.2019-12-23
COULTER LH
Beckman Coulter, Inc.2019-12-23
COULTER AcT
Beckman Coulter, Inc.2019-12-23
Access Intact PTH
Beckman Coulter, Inc.2019-12-23
Access Intact PTH Calibrators
Beckman Coulter, Inc.2019-12-23
UniCel DxH
Beckman Coulter, Inc.2019-12-23
COULTER AcT
Beckman Coulter, Inc.2019-12-23
COULTER AcT
Beckman Coulter, Inc.2019-12-23
COULTER AcT
Beckman Coulter, Inc.2019-12-23
COULTER AcT
Beckman Coulter, Inc.2019-12-23
Icon
Beckman Coulter, Inc.2019-12-16
ACTIVE Aldosterone RIA
Beckman Coulter, Inc.2019-12-05

Related Finance Registrations
BECKMAN COULTER INC of DELAWARE0000840467
Legal Entity Identifier 5493008CNCZVRJ77MV44 [Beckman Coulter, Inc.]

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