510(k) K183160

TEG 6s Hemostasis System, TEG 6s Citrated: K, RT, FF Assay Cartridge by Haemonetics Corporation — Product Code JPA

K183160 is an FDA 510(k) premarket notification submitted by Haemonetics Corporation for the device "TEG 6s Hemostasis System, TEG 6s Citrated: K, RT, FF Assay Cartridge". The FDA issued a decision of Substantially Equivalent on May 9, 2019. 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.