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Coagusense, Inc.
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COAGUSENSE SELF-TEST PROTHROMBIN TIME/INR MONITORING SYSTEM is an FDA 510(k)-cleared medical device (K093243) manufactured by Coagusense, 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 April 6, 2010. Regulation: 8.