Aesku Diagnostics

Aesku Diagnostics — FDA 510(k) Submissions

Aesku Diagnostics has submitted 9 FDA 510(k) premarket notifications since 2004, of which 9 received clearance as substantially equivalent to a predicate device.

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