Biokit USA, Inc.

Biokit USA, Inc. — FDA 510(k) Submissions

Biokit USA, Inc. has submitted 16 FDA 510(k) premarket notifications since 1984, of which 16 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Antistreptolysin - Titer/streptolysin O Reagent, System, Test, Rheumatoid Factor, Latex Agglutination Assay, Rubella, System, Test, C-reactive Protein, Antisera, Control For Nontreponemal Tests . Use the specialty filter in the sidebar to narrow results.