Roche Diagnostics Operations (Rdo)

Roche Diagnostics Operations (Rdo) — FDA 510(k) Submissions

Roche Diagnostics Operations (Rdo) has submitted 14 FDA 510(k) premarket notifications since 2014, of which 14 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Hemoglobin A1c Test System, Enzyme Immunoassay, Carbamazepine, Radioimmunoassay, Vancomycin, Differential Rate Kinetic Method, Cpk Or Isoenzymes, Test, Cystatin C . Use the specialty filter in the sidebar to narrow results.