510(k) K022046

VITAL SCIENTIFIC COAGULATION CONTROL,COAGULATION CONTROL LEVEL 1,2,3,QUIKCOAG COAGULATION CONTROL by Vital Scientific N.V. — Product Code GGN

K022046 is an FDA 510(k) premarket notification submitted by Vital Scientific N.V. for the device "VITAL SCIENTIFIC COAGULATION CONTROL,COAGULATION CONTROL LEVEL 1,2,3,QUIKCOAG COAGULATION CONTROL". The FDA issued a decision of Substantially Equivalent on July 23, 2002. The device falls under product code GGN (Plasma, Coagulation Control), a Class II device regulated under 21 CFR 864.5425. Vital Scientific N.V. has at least 4 other 510(k) clearances on record.