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Itc, Inc.
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HEMOCHRON JR. CITRATE APTT CUVETTE is an FDA 510(k)-cleared medical device (K014008) manufactured by Itc, Inc.. This device is classified under the Hematology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 23, 2002. Regulation: 8.