Roche Diagnostics/Boehringer Mannheim GmbH is one of 13079 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Roche Diagnostics/Boehringer Mannheim GmbH - FDA 510(k) Cleared Devic...
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
3
Total
3
Cleared
0
Denied
Roche Diagnostics/Boehringer Mannheim GmbH has 3 FDA 510(k) cleared medical devices. Based in Indianpolis, US.
Historical record: 3 cleared submissions from 1998 to 1999. Primary specialty: Chemistry.
Browse the FDA 510(k) cleared devices submitted by Roche Diagnostics/Boehringer Mannheim GmbH Filter by specialty or product code using the sidebar.
FDA 510(k) Regulatory Record - Roche Diagnostics/Boehringer Mannheim GmbH
3 devices
Cleared
Apr 13, 1999
COAGUCHEK PRO SYSTEM, APTT TEST CARTRIDGES FOR COAGUCHEK PRO SYSTEM, APTT...
Hematology
161d
Cleared
Aug 25, 1998
CEDIA RED BLOOD CELL FOLATE REAGENT PACK, CEDIA FOLATE ASSAY AND ELECSYS...
Chemistry
84d
Cleared
Jun 15, 1998
ROCHE DIAGNOSTICS, BOEHRINGER MANNHEIM LIQUID TOTAL BILIRUBIN REAGENT
Chemistry
38d