510(k) K854376

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

K854376 is an FDA 510(k) premarket notification submitted by Hemotec, Inc. for the device "HEMOTEC CITRATED WHOLE BLOOD COAGULATION CONTROLS". The FDA issued a decision of Substantially Equivalent on December 4, 1985. 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.