HARDYDISK AST TELAVANCIN,30UG

HARDYDISK AST TELAVANCIN,30UG is an FDA 510(k)-cleared medical device (K093807) 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 7, 2010. Regulation: 8.