Medical Device Manufacturer · DE , Mannheim

Roche Diagnostics GmbH - FDA 510(k) Cleared Devices

5 submissions · 5 cleared · Since 1998
5
Total
5
Cleared
0
Denied
FDA 510(k) Regulatory Record - Roche Diagnostics GmbH Chemistry ✕
3 devices
1-3 of 3
Cleared Apr 24, 2026
Elecsys Calcitonin
K252431 · JKR
Chemistry · 266d
Cleared Apr 24, 1998
ELECSYS CALCHECK FERRITIN
K981281 · JJX
Chemistry · 16d
Cleared Apr 23, 1998
ELECSYS CALCHECK CA 125II
K981278 · JJX
Chemistry · 15d
Filters
Filter by Specialty
All5 Chemistry 3 Immunology 1 General Hospital 1