Medical Device Manufacturer · US , Indianpolis , IN

Roche Diagnostics/Boehringer Mannheim GmbH - FDA 510(k) Cleared Devic...

3 submissions · 3 cleared · Since 1998

Recent clearances: COAGUCHEK PRO SYSTEM, APTT TEST CARTRIDGES FOR COAGUCHEK PRO SYSTEM, APTT CONTROLS FOR COAGUCHEK PRO SYSTEM, COAGUCHEK P, CEDIA RED BLOOD CELL FOLATE REAGENT PACK, CEDIA FOLATE ASSAY AND ELECSYS FOLATE ASSAY, ROCHE DIAGNOSTICS, BOEHRINGER MANNHEIM LIQUID TOTAL BILIRUBIN REAGENT

View 3 510(k) Devices ↓

3

Total

3

Cleared

0

Denied

FDA 510(k) Regulatory Record - Roche Diagnostics/Boehringer Mannheim GmbH Hematology ✕

1 devices

1-1 of 1

Cleared Apr 13, 1999

COAGUCHEK PRO SYSTEM, APTT TEST CARTRIDGES FOR COAGUCHEK PRO SYSTEM, APTT...

Hematology · 161d