510(k) K160502

TEG 6s Hemostasis System by Haemonetics Corporation — Product Code JPA

K160502 is an FDA 510(k) premarket notification submitted by Haemonetics Corporation for the device "TEG 6s Hemostasis System". The FDA issued a decision of Substantially Equivalent on April 19, 2017. The device falls under product code JPA (System, Multipurpose For In Vitro Coagulation Studies), a Class II device regulated under 21 CFR 864.5425. Haemonetics Corporation has at least 6 other 510(k) clearances on record.