Trinity Biotech USA

Trinity Biotech USA — FDA 510(k) Submissions

Trinity Biotech USA has submitted 11 FDA 510(k) premarket notifications since 1999, of which 11 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Reagent, Borrelia Serological Reagent, Enzyme Linked Immunoabsorbent Assay, Rubeola Igm, Lipoprotein, Low-density, Antigen, Antiserum, Control, Extractable Antinuclear Antibody, Antigen And Control, Legionella, Spp., Elisa . Use the specialty filter in the sidebar to narrow results.