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 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, 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, 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 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.
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 Ireland Inc.
Urine/CSF Albumin, Urine/CSF Albumin Calibrator2014-10-15
BECKMAN COULTER IRELAND INC
SYSTEM CALIBRATER2014-07-11
BECKMAN COULTER IRELAND INC
BICARBONATE CALIBRATOR2014-06-30
BECKMAN COULTER, INC
BECKMAN COULTER IMMAGE IMMUNOCHEMISTRY SYSTEM LOW CONCENTRATION IMMUNOGLOBULIN, BECKMAN COULTER2014-01-07
BECKMAN COULTER IRELAND INC
AU BICARBONATE REAGENT2013-10-09
BECKMAN COULTER, INC.
SYNCHRON SYSTEMS ENZYMATIC CREATININE (CR-E) REAGENT, MODEL A602982009-12-04
BECKMAN COULTER, INC.
SYNCHRON SYSTEMS ENZYMATIC CO2 (CO2E) REAGENT, MODEL A602912009-07-13
BECKMAN COULTER, INC.
IMMAGE IMMUNOCHEMISTRY SYSTEMS HIGH SENSITIVITY CARDIAC C-REACTIVE PROTEIN (CCRP) REAGENT2007-06-21
BECKMAN COULTER, INC.
SYNCHRON LX20 CLINICAL SYSTEMS, CREATININE TEST SYSTEMS2007-06-01
BECKMAN COULTER, INC.
IMMAGE SYSTEMS LOW CONCENTRATION IMMUNOGLOBULIN A REAGENT2006-02-13
BECKMAN COULTER, INC.
UNICEL DXC 600 AND 800 SYNCHRON SYSTEMS2004-11-12

Latest Premarket Applications

PMAManufacturerDevice NameDate
BECKMAN COULTER, INC.
Access AFP 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 PSA 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 Systems2019-07-31
BECKMAN COULTER, INC.
Access Hybritech p2PSA 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 AFP 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 AFP Immunoassay2017-10-24
BECKMAN COULTER, INC.
Access Hybritech p2PSA Reagents on the Access Immunoassay System2017-10-24
BECKMAN COULTER, INC.
Access Hybritech Free PSA Reagents on the Access Immunoassay Systems2017-07-07
BECKMAN COULTER, INC.
Access AFP Reagents on the Access Immunoassy 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 Hybritech Free PSA Reagents on the Access Immunoassay Systems2017-06-16
BECKMAN COULTER, INC.
Access Hybritech p2PSA 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 AFP Reagents on the Access Immunoassay Systems2017-06-16
BECKMAN COULTER, INC.
ACCESS HYBRITECH P2PSA ON THE ACCESS IMMUNOASSAY SYSTEMS2017-02-21
BECKMAN COULTER, INC.
ACCESS PSA CALIBRATORS ON THE ACCESS IMMUNOASSAY ANALYZER2017-02-14
BECKMAN COULTER, INC.
ACCESS AFP CALIBRATORS ON THE ACCESS IMMUNOASSAY ANALYZER2017-02-14
BECKMAN COULTER, INC.
ACCESS FREE PSA CALIBRATORS ON THE ACCESS IMMUNOASSAY ANALYZER2017-02-14

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
ACTIVE Aldosterone RIA
Beckman Coulter, Inc.2019-12-05
DxA 5000
Beckman Coulter, Inc.2019-11-12
IMMAGE
Beckman Coulter, Inc.2019-07-22
Kaluza C
Beckman Coulter, Inc.2019-06-12
Kaluza C
Beckman Coulter, Inc.2019-06-12
DxH 500 Series Calibrator
BECKMAN COULTER IRELAND INC.2019-05-09
DxH 500 Series Control
BECKMAN COULTER IRELAND INC.2019-05-09
Coulter 6C Plus Cell Control
Beckman Coulter, Inc.2019-04-19
ClearLLab 10C
BECKMAN COULTER IRELAND INC.2019-04-15
MicroScan
Beckman Coulter, Inc.2019-04-10
ClearLLab 10C
BECKMAN COULTER IRELAND INC.2019-04-03
ClearLLab 10C
BECKMAN COULTER IRELAND INC.2019-04-03
ClearLLab 10C
BECKMAN COULTER IRELAND INC.2019-04-03
ClearLLab 10C
BECKMAN COULTER IRELAND INC.2019-04-03
ClearLLab 10C
BECKMAN COULTER IRELAND INC.2019-04-03
ClearLLab 10C
BECKMAN COULTER IRELAND INC.2019-04-03
DxH 520
BECKMAN COULTER IRELAND INC.2019-04-01
AU
BECKMAN COULTER IRELAND INC.2019-03-11
Whole Blood Lysing Reagent
Beckman Coulter, Inc.2019-03-11
ISOFLOW SHEATH FLUID
Beckman Coulter, Inc.2019-03-11
MicroScan
Beckman Coulter, Inc.2019-03-11
MicroScan
Beckman Coulter, Inc.2019-03-11
MicroScan
Beckman Coulter, Inc.2019-03-11
Immuno-Brite Fluorospheres
Beckman Coulter, Inc.2019-03-11
MicroScan
Beckman Coulter, Inc.2019-03-11
MicroScan
Beckman Coulter, Inc.2019-03-11
MicroScan
Beckman Coulter, Inc.2019-03-11
APC Setup Kit
Beckman Coulter, Inc.2019-03-11
MicroScan
Beckman Coulter, Inc.2019-03-11
MicroScan
Beckman Coulter, Inc.2019-03-11
MicroScan
Beckman Coulter, Inc.2019-03-11
ISOFLOW SHEATH FLUID
Beckman Coulter, Inc.2019-03-11
PC7 Setup Kit
Beckman Coulter, Inc.2019-03-11
FLOW-CHECK
Beckman Coulter, Inc.2019-03-11
MicroScan
Beckman Coulter, Inc.2019-03-11

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