510(k) K251024

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

K251024 is an FDA 510(k) premarket notification submitted by Haemonetics for the device "TEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay Cartridge". The FDA issued a decision of Substantially Equivalent on April 30, 2025. 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 has at least 10 other 510(k) clearances on record.