Roche Diagnostic Systems, Inc.

Roche Diagnostic Systems, Inc. — FDA 510(k) Submissions

Roche Diagnostic Systems, Inc. has submitted 296 FDA 510(k) premarket notifications since 1983, of which 296 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Enzyme Immunoassay, Amphetamine, Drug Specific Control Materials, Drug Mixture Control Materials, Enzyme Immunoassay, Cannabinoids, Calibrators, Drug Mixture . Use the specialty filter in the sidebar to narrow results.