Medical Device Manufacturer · US , Indianapolos , IN

Roche Diagnostics Operations, Inc.

2 submissions · 2 cleared · Since 2013
2
Total
2
Cleared
0
Denied

Roche Diagnostics Operations, Inc. — FDA 510(k) Submissions

Roche Diagnostics Operations, Inc. has submitted 2 FDA 510(k) premarket notifications since 2013, of which 2 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include System, Test, Blood Glucose, Over The Counter, Glucose Dehydrogenase, Glucose . Use the specialty filter in the sidebar to narrow results.

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