Ortho-Clinical Diagnostics

Ortho-Clinical Diagnostics — FDA 510(k) Submissions

Ortho-Clinical Diagnostics has submitted 38 FDA 510(k) premarket notifications since 1999, of which 38 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Single (specified) Analyte Controls (assayed And Unassayed), Immunoassay Method, Troponin Subunit, C-reactive Protein, Antigen, Antiserum, And Control, Calibrator, Secondary, Fluorometric Method, Cpk Or Isoenzymes . Use the specialty filter in the sidebar to narrow results.