HARDYDISK AZITHROMYCIN 15MCG

HARDYDISK AZITHROMYCIN 15MCG is an FDA 510(k)-cleared medical device (K993994) 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 20, 1999. Regulation: 8.