Euroimmun US

Euroimmun US — FDA 510(k) Submissions

Euroimmun US has submitted 12 FDA 510(k) premarket notifications since 2012, of which 11 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Reagent, Borrelia Serological Reagent, Autoantibodies, Anti-soluble Liver Antigen (sla), Autoimmune Hepatitis, Anti-rnp Antibody, Antigen And Control, System, Test, Vitamin D, Antinuclear Antibody (enzyme-labeled), Antigen, Controls . Use the specialty filter in the sidebar to narrow results.