American Dade

American Dade — FDA 510(k) Submissions

American Dade has submitted 149 FDA 510(k) premarket notifications since 1980, of which 149 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Test, Qualitative And Quantitative Factor Deficiency, Multi-analyte Controls, All Kinds (assayed), Mixture, Hematology Quality Control, Tube, Collection, Capillary Blood, Calibrator, Secondary . Use the specialty filter in the sidebar to narrow results.