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Epitope Diagnostics, Inc.
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CARE FECAL OCCULT BLOOD TEST, MODEL KT313 is an FDA 510(k)-cleared medical device (K051806) manufactured by Epitope Diagnostics, 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 October 2, 2005. Regulation: 8.