Medical Device Manufacturer · US , Indianapolis , IN

Roche Professional Diagnostics - FDA 510(k) Cleared Devices

2 submissions · 2 cleared · Since 2010

Recent clearances: Elecsys CA-125 II assay, ANTI-HAV

View 2 510(k) Devices ↓

2

Total

2

Cleared

0

Denied

FDA 510(k) Regulatory Record - Roche Professional Diagnostics Immunology ✕

1 devices

1-1 of 1

Cleared Aug 06, 2015

Elecsys CA-125 II assay

Immunology · 237d