510(k) K250965

Automated Blood Coagulation Analyzer CN-Series (CN-6000) by Sysmex America, Inc. — Product Code JPA

K250965 is an FDA 510(k) premarket notification submitted by Sysmex America, Inc. for the device "Automated Blood Coagulation Analyzer CN-Series (CN-6000)". The FDA issued a decision of Substantially Equivalent on June 2, 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. Sysmex America, Inc. has at least 10 other 510(k) clearances on record.