Medical Device Manufacturer · US , Danbury , CT

Hologic

2 submissions · 2 cleared · Since 2016
2
Total
2
Cleared
0
Denied

Hologic — FDA 510(k) Submissions

Hologic has submitted 2 FDA 510(k) premarket notifications since 2016, of which 2 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include System, X-ray, Mammographic, Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-based Assay System . Use the specialty filter in the sidebar to narrow results.

2 devices
1–2 of 2
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All2 Radiology 1 Microbiology 1