BHI W/VANCOMYCIN AGAR

BHI W/VANCOMYCIN AGAR is an FDA 510(k)-cleared medical device (K964560) 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 14, 1997. Regulation: 8.