Roche Diagnostics - FDA 510(k) Cleared Devices

Cleared Jan 16, 2009

COBAS INTEGRA 400/800 BILIRUBIN TOTAL

K081193 · CIG

Chemistry · 263d

Cleared Aug 22, 2008

ELECSYS ANTI-TSHR CALCHECK

K080643 · JJX

Chemistry · 169d

Cleared Jul 15, 2008

ACCU-CHEK COMPACT PLUS BLOOD GLUCOSE MONITORING SYSTEM

K081389 · NBW

Chemistry · 57d

Cleared Feb 05, 2008

ELECSYS PROBNP II, PRECICONTROL CARDIAC II, PROBNP II CALSET

K072437 · NBC

Chemistry · 166d

Cleared Oct 05, 2007

ELECSYS CORTISOL TEST SYSTEM

K070788 · NHG

Chemistry · 197d

Cleared Sep 14, 2007

TOTAL PROTEIN URINE/CSF GEN.3

K071239 · JGQ

Chemistry · 134d

Cleared Jul 30, 2007

COBAS C 111 ANALYZER

K071211 · CIT

Chemistry · 90d

Cleared Nov 28, 2005

ROCHE DIAGNOSTICS ELECSYS PROLACTIN II CALCHECK

K053059 · JJX

Chemistry · 28d

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