510(k) K954202

PLATELET FUNCTION TEST ASSAY CARTRIDGES FOR THE HEPCON HMS by Medtronic Hemotec, Inc. — Product Code JPA

K954202 is an FDA 510(k) premarket notification submitted by Medtronic Hemotec, Inc. for the device "PLATELET FUNCTION TEST ASSAY CARTRIDGES FOR THE HEPCON HMS". The FDA issued a decision of Substantially Equivalent on June 20, 1996. The device falls under product code JPA (System, Multipurpose For In Vitro Coagulation Studies), a Class II device regulated under 21 CFR 864.5425. Medtronic Hemotec, Inc. has at least 4 other 510(k) clearances on record.