Medical Device Manufacturer · US , Indianapolos , IN

Roche

2 submissions · 2 cleared · Since 2011
2
Total
2
Cleared
0
Denied

Roche — FDA 510(k) Submissions

Roche has submitted 2 FDA 510(k) premarket notifications since 2011, of which 2 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Assay, Glycosylated Hemoglobin, Urinary Homocystine (nonquantitative) Test System . Use the specialty filter in the sidebar to narrow results.

2 devices
1–2 of 2
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