510(k) K031377

SYSMEX AUTOMATED COAGULATION ANALYZER CA500 SERIES (CA-510, -520, -530, -540. -550, AND -560 by Dade Behring, Inc. — Product Code GKP

K031377 is an FDA 510(k) premarket notification submitted by Dade Behring, Inc. for the device "SYSMEX AUTOMATED COAGULATION ANALYZER CA500 SERIES (CA-510, -520, -530, -540. -550, AND -560". The FDA issued a decision of Substantially Equivalent on September 8, 2003. 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.