510(k) K020979

SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL #CA-7000 by Dade Behring, Inc. — Product Code GKP

K020979 is an FDA 510(k) premarket notification submitted by Dade Behring, Inc. for the device "SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL #CA-7000". The FDA issued a decision of Substantially Equivalent on June 27, 2002. The device falls under product code GKP (Instrument, Coagulation, Automated), a Class II device regulated under 21 CFR 864.5400. Dade Behring, Inc. has at least 10 other 510(k) clearances on record.