Applications Lab

Applications Lab — FDA 510(k) Submissions

Applications Lab has submitted 10 FDA 510(k) premarket notifications since 1985, of which 10 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include C-reactive Protein, Antigen, Antiserum, And Control, Alpha-2-macroglobulin, Antigen, Antiserum, Control, Iga, Antigen, Antiserum, Control, Igg, Antigen, Antiserum, Control, Haptoglobin, Antigen, Antiserum, Control . Use the specialty filter in the sidebar to narrow results.