Roche Diagnostics - FDA 510(k) Cleared Devices

Cleared Oct 28, 2005

ROCHE DIAGNOSTICS COBAS ELECSYS PROLACTIN II CALSET

K052982 · JIT

Chemistry · 4d

Cleared Oct 03, 2005

ISE COMPENSATOR

K052193 · JIT

Chemistry · 53d

Cleared Aug 26, 2005

C.F.A.S. (CALIBRATOR FOR AUTOMATED SYSTEMS) HBA1C

K052101 · KRZ

Chemistry · 23d

Cleared Aug 23, 2005

ACCUCHEK INSTANT PLUS DUAL TESTING SYSTEM, ACCUCHEK INSTANT PLUS CHOLESTEROL,...

K051376 · CHH

Chemistry · 89d

Cleared Jul 11, 2005

ROCHE ELECSYS TROPONIN T STAT (SHORT TURNAROUND TIME)

K051752 · MMI

Chemistry · 12d

Cleared Apr 22, 2005

OMNI MODULAR, OMNI C AND OMNI S ANALYZER (PH ELECTRODE)

K050423 · CHL

Chemistry · 63d

Cleared Jan 31, 2005

PRECINORM PROTEINS IN URINE/CSF (PUC) AND PRECIPATH PUC

K050026 · JIX

Chemistry · 25d