Rhigene, Inc.

Rhigene, Inc. — FDA 510(k) Submissions

Rhigene, Inc. has submitted 15 FDA 510(k) premarket notifications since 2000, of which 15 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Extractable Antinuclear Antibody, Antigen And Control, Antinuclear Antibody (enzyme-labeled), Antigen, Controls, Test System, Antineutrophil Cytoplasmic Antibodies (anca), Anti-rnp Antibody, Antigen And Control, Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control . Use the specialty filter in the sidebar to narrow results.