HARDYDISK AST DORIPENEM 10 UG

HARDYDISK AST DORIPENEM 10 UG is an FDA 510(k)-cleared medical device (K080019) manufactured by Hardy Diagnostics. This device is classified under the Microbiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 28, 2008. Regulation: 8.