Sweden Diagnostics (Germany) GmbH

Sweden Diagnostics (Germany) GmbH — FDA 510(k) Submissions

Sweden Diagnostics (Germany) GmbH has submitted 8 FDA 510(k) premarket notifications since 2004, of which 8 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Autoantibodies, Endomysial(tissue Transglutaminase), Antibodies, Gliadin, Antinuclear Antibody (enzyme-labeled), Antigen, Controls, Test System, Antineutrophil Cytoplasmic Antibodies (anca), Anti-sm Antibody, Antigen And Control . Use the specialty filter in the sidebar to narrow results.