
International Technidyne Corp.
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HEMOCHRON CONTROL PLASMA NORMAL/ABNORMAL LEV. I/II is an FDA 510(k)-cleared medical device (K882480) manufactured by International Technidyne 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 August 29, 1988. Regulation: 8.