Ortho-Clinical Diagnostics, Inc.

Ortho-Clinical Diagnostics, Inc. — FDA 510(k) Submissions

Ortho-Clinical Diagnostics, Inc. has submitted 106 FDA 510(k) premarket notifications since 1997, of which 104 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Single (specified) Analyte Controls (assayed And Unassayed), Enzymatic Method, Creatinine, Multi-analyte Controls, All Kinds (assayed), Calibrator, Multi-analyte Mixture, Immunoassay Method, Troponin Subunit . Use the specialty filter in the sidebar to narrow results.