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.
| Manufacturer | Device Name | Date |
|---|---|---|
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 B12 | 2019-10-04 |
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 Cytometer | 2019-03-21 |
Beckman Coulter | Unicel DxH 800 Cellular Analysis System With Early Sepsis Indicator Application | 2019-03-18 |
Beckman Coulter | DxH 520 Hematology Instrument | 2019-03-01 |
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 HsTnl | 2018-06-14 |
Beckman Coulter, Inc. | Access Hs Tnl | 2018-06-12 |
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 AMH | 2017-11-13 |
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 Laser | 2017-06-23 |
BECKMAN COULTER IRELAND INC. | Ceruloplasmin | 2017-01-09 |
BECKMAN COULTER INC. | ISE Reagent, Glucose, CRP Latex, DxC 700 AU Clinical Chemistry Analyzer | 2016-12-16 |
BECKMAN COULTER, INC. | UniCel DxH SlideMaker Stainer Coulter Cellular Analysis System | 2016-11-29 |
BECKMAN COULTER, INC. | AQUIOS CL FLOW CYTOMETER, AQUIOS TETRA-1 PANEL,AQUIOS TETRA-2+PANEL, AQUIOS IMMUNO-TROL, AQUIOS IMMUNO-TROL LOW, AQUIOS | 2015-04-10 |
BECKMAN COULTER, INC. | UniCel DxC SYNCHRON System HDL Cholesterol Reagent(HDL),Unicel DxC SYNCHRON System HDL Calibrator | 2015-02-26 |
Beckman Coulter Ireland Inc. | Urine/CSF Albumin, Urine/CSF Albumin Calibrator | 2014-10-15 |
BECKMAN COULTER IRELAND INC | SYSTEM CALIBRATER | 2014-07-11 |
BECKMAN COULTER IRELAND INC | BICARBONATE CALIBRATOR | 2014-06-30 |
BECKMAN COULTER, INC | BECKMAN COULTER IMMAGE IMMUNOCHEMISTRY SYSTEM LOW CONCENTRATION IMMUNOGLOBULIN, BECKMAN COULTER | 2014-01-07 |
BECKMAN COULTER IRELAND INC | AU BICARBONATE REAGENT | 2013-10-09 |
BECKMAN COULTER, INC. | SYNCHRON SYSTEMS ENZYMATIC CREATININE (CR-E) REAGENT, MODEL A60298 | 2009-12-04 |
BECKMAN COULTER, INC. | SYNCHRON SYSTEMS ENZYMATIC CO2 (CO2E) REAGENT, MODEL A60291 | 2009-07-13 |
BECKMAN COULTER, INC. | IMMAGE IMMUNOCHEMISTRY SYSTEMS HIGH SENSITIVITY CARDIAC C-REACTIVE PROTEIN (CCRP) REAGENT | 2007-06-21 |
BECKMAN COULTER, INC. | SYNCHRON LX20 CLINICAL SYSTEMS, CREATININE TEST SYSTEMS | 2007-06-01 |
BECKMAN COULTER, INC. | IMMAGE SYSTEMS LOW CONCENTRATION IMMUNOGLOBULIN A REAGENT | 2006-02-13 |
BECKMAN COULTER, INC. | UNICEL DXC 600 AND 800 SYNCHRON SYSTEMS | 2004-11-12 |
| PMA | Manufacturer | Device Name | Date |
|---|---|---|---|
BECKMAN COULTER, INC. | Access AFP Reagents on the Access Immunoassay Systems | 2019-08-09 | |
BECKMAN COULTER, INC. | Access Hybritech Free PSA Reagents on the Access Immunoassay Systems | 2019-08-09 | |
BECKMAN COULTER, INC. | Access Hybritech PSA Reagents on the Access Immunoassay Systems | 2019-08-09 | |
BECKMAN COULTER, INC. | Access Hybritech p2PSA Reagents on the Access Immunoassay Systems | 2019-08-09 | |
BECKMAN COULTER, INC. | Access Hybritech Free PSA Reagents on the Access Immunoassay Systems | 2019-07-31 | |
BECKMAN COULTER, INC. | Access Hybritech p2PSA Reagents on the Access Immunoassay Systems | 2019-07-31 | |
BECKMAN COULTER, INC. | Access Hybritech PSA Reagents on the Access Immunoassay Systems | 2019-07-31 | |
BECKMAN COULTER, INC. | Access AFP Reagents on the Access Immunoassay Systems | 2019-07-31 | |
BECKMAN COULTER, INC. | Access Hybritech p2PSA Reagent Pack | 2019-01-09 | |
BECKMAN COULTER, INC. | Access Hybritech Free PSA Reagents on the Access Immunoassay Systems | 2018-12-21 | |
BECKMAN COULTER, INC. | Acess AFP Reagents on the Access Immunoassay Systems | 2018-12-21 | |
BECKMAN COULTER, INC. | Access Hybritech p2PSA Reagents on the Access Immunoassay Systems | 2018-12-21 | |
BECKMAN COULTER, INC. | Access Hybritech PSA Reagents on the Access Immunoassay Systems | 2018-12-21 | |
BECKMAN COULTER, INC. | Access AFP Reagents on the Access Immunoassay Systems | 2018-09-12 | |
BECKMAN COULTER, INC. | Access Hybritech PSA Assay | 2017-10-24 | |
BECKMAN COULTER, INC. | Access Hybritech free PSA Reagents/Calibrator Kit Immunoassay Systems | 2017-10-24 | |
BECKMAN COULTER, INC. | Access AFP Immunoassay | 2017-10-24 | |
BECKMAN COULTER, INC. | Access Hybritech p2PSA Reagents on the Access Immunoassay System | 2017-10-24 | |
BECKMAN COULTER, INC. | Access Hybritech Free PSA Reagents on the Access Immunoassay Systems | 2017-07-07 | |
BECKMAN COULTER, INC. | Access AFP Reagents on the Access Immunoassy Systems | 2017-07-07 | |
BECKMAN COULTER, INC. | Access Hybritech p2PSA Reagents on the Access Immunoassay Systems | 2017-07-07 | |
BECKMAN COULTER, INC. | Access Hybritech PSA Reagents on the Access Immunoassy Systems | 2017-07-07 | |
BECKMAN COULTER, INC. | Access Hybritech Free PSA Reagents on the Access Immunoassay Systems | 2017-06-16 | |
BECKMAN COULTER, INC. | Access Hybritech p2PSA Reagents on the Access Immunoassay Systems | 2017-06-16 | |
BECKMAN COULTER, INC. | Access Hybritech PSA Reagents on the Access Immunoassay Systems | 2017-06-16 | |
BECKMAN COULTER, INC. | Access AFP Reagents on the Access Immunoassay Systems | 2017-06-16 | |
BECKMAN COULTER, INC. | ACCESS HYBRITECH P2PSA ON THE ACCESS IMMUNOASSAY SYSTEMS | 2017-02-21 | |
BECKMAN COULTER, INC. | ACCESS PSA CALIBRATORS ON THE ACCESS IMMUNOASSAY ANALYZER | 2017-02-14 | |
BECKMAN COULTER, INC. | ACCESS AFP CALIBRATORS ON THE ACCESS IMMUNOASSAY ANALYZER | 2017-02-14 | |
BECKMAN COULTER, INC. | ACCESS FREE PSA CALIBRATORS ON THE ACCESS IMMUNOASSAY ANALYZER | 2017-02-14 |
| De Novo | Manufacturer | Device Name | Date |
|---|---|---|---|
Beckman Coulter | ClearLLab T1, ClearLLab T2, ClearLLab B1, ClearLLab B2, ClearLLab M | 2017-06-29 |
Device GUDID Device Name | Manufacturer | Date |
|---|---|---|
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 |