HARDYDISK GENTAMICIN, 10MCG

HARDYDISK GENTAMICIN, 10MCG is an FDA 510(k)-cleared medical device (K994091) 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 February 10, 2000. Regulation: 8.