Medical Device Manufacturer · US , Rockville , MD

Opgen, Inc.

1 submissions · 1 cleared · Since 2021
1
Total
1
Cleared
0
Denied

Opgen, Inc. — FDA 510(k) Submissions

Opgen, Inc. has submitted 1 FDA 510(k) premarket notifications since 2021, of which 1 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include System, Nucleic Acid Amplification Test, Dna, Carbapenem Non-susceptible Gram Negative Organism, Colony . Use the specialty filter in the sidebar to narrow results.

1 devices
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