Roche Diagnostics Operations

Roche Diagnostics Operations — FDA 510(k) Submissions

Roche Diagnostics Operations has submitted 5 FDA 510(k) premarket notifications since 2012, of which 5 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Albumin, Antigen, Antiserum, Control, Hemoglobin A1c Test System, Assay, Glycosylated Hemoglobin, Enzyme Immunoassay, Methotrexate, Lipoprotein, Low-density, Antigen, Antiserum, Control . Use the specialty filter in the sidebar to narrow results.