Medical Device Manufacturer · DE , Munich

Beckman Coulter Biomedical GmbH - FDA 510(k) Cleared Devices

1 submissions · 1 cleared · Since 2019

Recent clearances: DxA 5000, DxI 800 Access Immunoassay System, Access Ferritin, Access Folate, Access TSH (3rd IS), Access Vitamin B12

1

Total

1

Cleared

0

Denied

FDA 510(k) Regulatory Record - Beckman Coulter Biomedical GmbH Chemistry ✕

1 devices

1-1 of 1

Cleared Oct 04, 2019

DxA 5000, DxI 800 Access Immunoassay System, Access Ferritin, Access Folate,...

Chemistry · 235d