510(k) K984141

GBACT + KIT by Sienco, Inc. — Product Code JBP

K984141 is an FDA 510(k) premarket notification submitted by Sienco, Inc. for the device "GBACT + KIT". The FDA issued a decision of Substantially Equivalent on May 28, 1999. 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.