510(k) K894359

CLOTRAC CITRATED WHOLE BLOOD COAGULATION CONTROLS by Hemotec, Inc. — Product Code JPA

K894359 is an FDA 510(k) premarket notification submitted by Hemotec, Inc. for the device "CLOTRAC CITRATED WHOLE BLOOD COAGULATION CONTROLS". The FDA issued a decision of Substantially Equivalent on September 5, 1989. The device falls under product code JPA (System, Multipurpose For In Vitro Coagulation Studies), a Class II device regulated under 21 CFR 864.5425. Hemotec, Inc. has at least 10 other 510(k) clearances on record.