Medical Device Manufacturer · DE , Mannheim

Roche Diabetes Care GmbH - FDA 510(k) Cleared Devices

2 submissions · 2 cleared · Since 2023
2
Total
2
Cleared
0
Denied
FDA 510(k) Regulatory Record - Roche Diabetes Care GmbH Chemistry ✕
2 devices
1-2 of 2
Cleared Aug 10, 2023
Accu-Chek Guide Solo diabetes manager blood glucose monitoring system
K213131 · NBW
Chemistry · 682d
Cleared Aug 10, 2023
Accu-Chek Solo micropump system with interoperable technology
K213134 · QFG
Chemistry · 682d
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