Medical Device Manufacturer · US , Somerville , NJ

Roche Molecular Systems, Inc. - FDA 510(k) Cleared Devices

49 submissions · 46 cleared · Since 1993

49

Total

46

Cleared

3

Denied

FDA 510(k) cleared devices by Roche Molecular Systems, Inc. Chemistry ✕

4 devices

1-4 of 4

Cleared Jan 10, 2005

ROCHE AMPLICHIP CYP450 TEST

Chemistry · 14d

Not Cleared Dec 23, 2004

AMPLICHIP CYP450 TEST, MODEL 04381866190

DEN040011 · NTI

Chemistry · 3d

Cleared Feb 01, 2002

ROCHE COBAS TAQMAN ANALYZER

Chemistry · 150d

Cleared May 21, 1997

ROCHE COBAS AMPLICOR ANALYZER

Chemistry · 194d