
Clin Tech Diagnostics Corp.
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GLYCO-TROL HUMAN GLYCOSYLATED HOM. CONT. is an FDA 510(k)-cleared medical device (K802432) manufactured by Clin Tech Diagnostics Corp.. This device is classified under the Hematology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 30, 1980. Regulation: 8.