Medical Device Manufacturer · US , Indianapolos , IN

Rochdiag - FDA 510(k) Cleared Devices

3 submissions · 3 cleared · Since 2001

Recent clearances: COBAS INTEGRA C 111, CALIBRATOR FOR AUTOMATED SYSTEMS (C.F.A.S.) LIPIDS, TINA-QUANT ALPHA-1 ANTITRYPSIN

View 3 510(k) Devices ↓

3

Total

3

Cleared

0

Denied

FDA 510(k) Regulatory Record - Rochdiag Chemistry ✕

2 devices

1-2 of 2

Cleared Jan 17, 2007

COBAS INTEGRA C 111

Chemistry · 30d

Cleared Jul 31, 2001

CALIBRATOR FOR AUTOMATED SYSTEMS (C.F.A.S.) LIPIDS

Chemistry · 63d