Hemagen Diagnostics, Inc.

Hemagen Diagnostics, Inc. — FDA 510(k) Submissions

Hemagen Diagnostics, Inc. has submitted 52 FDA 510(k) premarket notifications since 1986, of which 52 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Extractable Antinuclear Antibody, Antigen And Control, C-reactive Protein, Antigen, Antiserum, And Control, System, Test, Anticardiolipin Immunological, Test System, Antineutrophil Cytoplasmic Antibodies (anca), System,test,antibodies,b2 - Glycoprotein I (b2 - Gpi) . Use the specialty filter in the sidebar to narrow results.