
Hardy Diagnostics
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HARDY DISK AST TIGECYCLINE 15 UG, MODELZ936 is an FDA 510(k)-cleared medical device (K062245) 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 August 22, 2006. Regulation: 8.