Medical Device Manufacturer · US , Chelmsford , MA

First Light Diagnostics, Inc.

2 submissions · 2 cleared · Since 2021
2
Total
2
Cleared
0
Denied

First Light Diagnostics, Inc. — FDA 510(k) Submissions

First Light Diagnostics, Inc. has submitted 2 FDA 510(k) premarket notifications since 2021, of which 2 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Reagents, Clostridium Difficile Toxin, Simple In Vitro Diagnostic Device For The Detection Of Secreted Proteins From Bacillus Spp. In Human Clinical Samples . Use the specialty filter in the sidebar to narrow results.

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