
Hardy Diagnostics
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HARDY DISK, CEFPODOXINE, 10MCG is an FDA 510(k)-cleared medical device (K003532) 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 12, 2000. Regulation: 8.