Alpkem Corp.

Alpkem Corp. — FDA 510(k) Submissions

Alpkem Corp. has submitted 33 FDA 510(k) premarket notifications since 1985, of which 33 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Nad Reduction/nadh Oxidation, Lactate Dehydrogenase, Enzymatic Esterase--oxidase, Cholesterol, Lipase Hydrolysis/glycerol Kinase Enzyme, Triglycerides, Analyzer, Chemistry, Micro, For Clinical Use, Acid, Uric, Uricase (colorimetric) . Use the specialty filter in the sidebar to narrow results.