Genalyte, Inc.

Genalyte, Inc. — FDA 510(k) Submissions

Genalyte, Inc. has submitted 2 FDA 510(k) premarket notifications since 2019, of which 2 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Anti-rnp Antibody, Antigen And Control, Radioimmunoassay, Thyroid-stimulating Hormone . Use the specialty filter in the sidebar to narrow results.