Genbio

Genbio — FDA 510(k) Submissions

Genbio has submitted 10 FDA 510(k) premarket notifications since 1996, of which 10 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Epstein-barr Virus, Other, Reagent, Borrelia Serological Reagent, Enzyme Linked Immunoabsorbent Assay, Mycoplasma Spp., Test, Antigen, Nuclear, Epstein-barr Virus, Antibody Igm, If, Epstein-barr Virus . Use the specialty filter in the sidebar to narrow results.