Roche Diagnostics

Roche Diagnostics — FDA 510(k) Submissions

Roche Diagnostics has submitted 177 FDA 510(k) premarket notifications since 2005, of which 175 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Single (specified) Analyte Controls (assayed And Unassayed), Calibrator, Secondary, Test, Time, Prothrombin, System, Test, Blood Glucose, Over The Counter, Multi-analyte Controls, All Kinds (assayed) . Use the specialty filter in the sidebar to narrow results.