
Hardy Diagnostics
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HARDYDISK NOVOBIOCIN, 30MCG, MODEL Z883 is an FDA 510(k)-cleared medical device (K011384) 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 June 12, 2001. Regulation: 8.