Medical Device Manufacturer · US , Bedford , MA

Genabio Diagnostics, Inc.

2 submissions · 2 cleared · Since 2024
2
Total
2
Cleared
0
Denied

Genabio Diagnostics, Inc. — FDA 510(k) Submissions

Genabio Diagnostics, Inc. has submitted 2 FDA 510(k) premarket notifications since 2024, of which 2 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Over-the-counter Covid-19 Antigen Test, Polymer Patient Examination Glove . Use the specialty filter in the sidebar to narrow results.

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