Medical Device Manufacturer · US , Indianapolos , IN

Roche Diagnostics - FDA 510(k) Cleared Devices

188 submissions · 185 cleared · Since 2005

View 188 510(k) Devices ↓ Official Website

188

Total

185

Cleared

3

Denied

31 devices

26-31 of 31

Cleared Jul 25, 2012

ELECSYS HSV-1 IGG IMMUNOASSAY ELECSYS PRECICONTROL HSV

Microbiology · 146d

Cleared Jun 22, 2010

Microbiology · 181d

Cleared Mar 12, 2010

ELECSYS RUBELLA IGM IMMUNOASSAY

Microbiology · 220d

Cleared Oct 30, 2009

ELECSYS RUBELLA IGGA CALCHECK 5

Microbiology · 67d

Cleared May 05, 2009

ELECSYS RUBELLA IGG CALCHECK

Microbiology · 88d

Cleared Feb 12, 2009

ELECSYS TOXO IGG CALCHECK

Microbiology · 64d