HARDYDISK AMIKACIN 30MCG

HARDYDISK AMIKACIN 30MCG is an FDA 510(k)-cleared medical device (K993993) 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 December 26, 1999. Regulation: 8.