Medical Device Manufacturer · DE , Mannheim

Roche Diagnostics GmbH - FDA 510(k) Cleared Devices

5 submissions · 5 cleared · Since 1998

Total

Cleared

Denied

Roche Diagnostics GmbH has 5 FDA 510(k) cleared medical devices. Based in Mannheim, DE.

Latest FDA clearance: Apr 2026. Active since 1998. Primary specialty: Chemistry.

Browse the FDA 510(k) cleared devices submitted by Roche Diagnostics GmbH Filter by specialty or product code using the sidebar.

FDA 510(k) Regulatory Record - Roche Diagnostics GmbH

5 devices

1-5 of 5