510(k) K002528

SONOCLOT COAGULATION & PLATELET FUNCTION ANALYZER SYSTEM WITH SIGNATURE VIEWER OPTION by Sienco, Inc. — Product Code JBP

K002528 is an FDA 510(k) premarket notification submitted by Sienco, Inc. for the device "SONOCLOT COAGULATION & PLATELET FUNCTION ANALYZER SYSTEM WITH SIGNATURE VIEWER OPTION". The FDA issued a decision of Substantially Equivalent on August 31, 2000. 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.