Elan Diagnostics

Elan Diagnostics — FDA 510(k) Submissions

Elan Diagnostics has submitted 13 FDA 510(k) premarket notifications since 1999, of which 13 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Diazo Colorimetry, Bilirubin, Calibrator, Multi-analyte Mixture, Hexokinase, Glucose, Ldl & Vldl Precipitation, Hdl, Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes . Use the specialty filter in the sidebar to narrow results.