Roche Professional Diagnostics

Roche Professional Diagnostics — FDA 510(k) Submissions

Roche Professional Diagnostics has submitted 2 FDA 510(k) premarket notifications since 2010, of which 2 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Hepatitis A Test (antibody And Igm Antibody), Test, Epithelial Ovarian Tumor-associated Antigen (ca125) . Use the specialty filter in the sidebar to narrow results.