A-Kem, Inc.

A-Kem, Inc. — FDA 510(k) Submissions

A-Kem, Inc. has submitted 13 FDA 510(k) premarket notifications since 1987, of which 13 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Biuret (colorimetric), Total Protein, Electrode, Ion Specific, Sodium, Amyloclastic, Amylase, Coulometric, Chloride, Calibrator, Multi-analyte Mixture . Use the specialty filter in the sidebar to narrow results.