Medical Device Manufacturer · US , Indianapolos , IN

Roche Diagnostics - FDA 510(k) Cleared Devices

188 submissions · 185 cleared · Since 2005

Recent clearances: Elecsys EBV EBNA IgG, Elecsys EBV VCA IgG, Elecsys EBV IgM

View 188 510(k) Devices ↓ Official Website
188
Total
185
Cleared
3
Denied

FDA 510(k) Regulatory Record - Roche Diagnostics General Hospital ✕

2 devices
1-2 of 2
Cleared Jul 17, 2012
ACCU-CHECK COMBO SYSTEM
K111353 · LZG
General Hospital · 428d
Cleared Oct 28, 2008
MODIFICATION TO:ACCU-CHEK POCKET COMPASS DIABETES MANAGEMENT SOFTWARE
K082595 · LZG
General Hospital · 50d
Filters
Filter by Specialty
All188 Chemistry 117 Microbiology 31 Immunology 25 Hematology 8 Toxicology 5 General Hospital 2