Arkray, Inc.

Arkray, Inc. — FDA 510(k) Submissions

Arkray, Inc. has submitted 18 FDA 510(k) premarket notifications since 2002, of which 18 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Method, Enzymatic, Glucose (urinary, Non-quantitative), Cresolphthalein Complexone, Calcium, Automated Urinalysis System, Enzymatic Esterase--oxidase, Cholesterol, Alkaline Picrate, Colorimetry, Creatinine . Use the specialty filter in the sidebar to narrow results.