510(k) K223635

Sonoclot Coagulation & Platelet Function Analyzer System with Sonoclot Viewer by Sienco, Inc. — Product Code JBP

K223635 is an FDA 510(k) premarket notification submitted by Sienco, Inc. for the device "Sonoclot Coagulation & Platelet Function Analyzer System with Sonoclot Viewer". The FDA issued a decision of Substantially Equivalent on January 4, 2023. The device falls under product code JBP (Activated Whole Blood Clotting Time), a Class II device regulated under 21 CFR 864.7140. Sienco, Inc. has at least 4 other 510(k) clearances on record.