Fujirebio Diagnostics,Inc.

Fujirebio Diagnostics,Inc. — FDA 510(k) Submissions

Fujirebio Diagnostics,Inc. has submitted 45 FDA 510(k) premarket notifications since 1989, of which 43 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, System, Test, Carbohydrate Antigen (ca19-9), For Monitoring And Management Of Pancreatic Cancer, Test, Epithelial Ovarian Tumor Associated Antigen (he4), Ovarian Adnexal Mass Assessment Score Test System . Use the specialty filter in the sidebar to narrow results.