Medical Device Manufacturer · US , Indianapolos , IN

Roche - FDA 510(k) Cleared Devices

2 submissions · 2 cleared · Since 2011

Recent clearances: HOMOCYSTEINE TEST, TQ HBA1C GEN3

View 2 510(k) Devices ↓

2

Total

2

Cleared

0

Denied

FDA 510(k) Regulatory Record - Roche Chemistry ✕

2 devices

1-2 of 2

Cleared Jun 05, 2012

HOMOCYSTEINE TEST

Chemistry · 165d

Cleared Jan 20, 2011

Chemistry · 111d