510(k) K232018

Citrated: K, KH, RTH, FFH by Haemonetics Corporation — Product Code JPA

K232018 is an FDA 510(k) premarket notification submitted by Haemonetics Corporation for the device "Citrated: K, KH, RTH, FFH". The FDA issued a decision of Substantially Equivalent on March 29, 2024. 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.