Harleco

Harleco — FDA 510(k) Submissions

Harleco has submitted 116 FDA 510(k) premarket notifications since 1976, of which 116 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Alkaline Picrate, Colorimetry, Creatinine, Hexokinase, Glucose, Diazo Colorimetry, Bilirubin, Biuret (colorimetric), Total Protein, Nad Reduction/nadh Oxidation, Cpk Or Isoenzymes . Use the specialty filter in the sidebar to narrow results.