Hardy Diagnostics

Hardy Diagnostics — FDA 510(k) Submissions

Hardy Diagnostics has submitted 108 FDA 510(k) premarket notifications since 1993, of which 108 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Susceptibility Test Discs, Antimicrobial, Discs, Strips And Reagents, Microorganism Differentiation, Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar, Gbs Culture Media, Selective And Differential, Culture Media, Non-propagating Transport . Use the specialty filter in the sidebar to narrow results.