OraSure Technologies, Inc.

OraSure Technologies, Inc. — FDA 510(k) Submissions

OraSure Technologies, Inc. has submitted 30 FDA 510(k) premarket notifications since 1996, of which 29 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Unit, Cryosurgical, Accessories, Enzyme Immunoassay, Cocaine And Cocaine Metabolites, Enzyme Immunoassay, Nicotine And Nicotine Metabolites, Enzyme Immunoassay, Barbiturate, Enzyme Immunoassay, Cannabinoids . Use the specialty filter in the sidebar to narrow results.