Medical Device Manufacturer · US , Indianapolis, , IN

Roche Diabetes Care, Inc. - FDA 510(k) Cleared Devices

9 submissions · 9 cleared · Since 2015
9
Total
9
Cleared
0
Denied
FDA 510(k) Regulatory Record - Roche Diabetes Care, Inc. Chemistry ✕
2 devices
1-2 of 2
Cleared May 06, 2022
IWL2020 Blood Glucose Monitoring System
K203711 · NBW
Chemistry · 501d
Cleared Aug 31, 2016
ACCU-CHEK Guide Blood Glucose Monitoring System
K160944 · NBW
Chemistry · 148d
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