Randox Laboratories Limited

Randox Laboratories Limited — FDA 510(k) Submissions

Randox Laboratories Limited has submitted 18 FDA 510(k) premarket notifications since 2004, of which 18 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Multi-analyte Controls, All Kinds (assayed), Enzyme Immunoassay, Opiates, Enzymatic Method, Bilirubin, Urinalysis Controls (assayed And Unassayed), Calibrator, Primary . Use the specialty filter in the sidebar to narrow results.