510(k) K063655

DIMENSION VISTA; CER FLEX REAGENT CARTRIDGE, PROTEIN 1 CALIBRATOR, PROTEIN 1 CONTROL MEDIUM, PROTEIN 1 CONTROL HIGH by Dade Behring, Inc. — Product Code CHN

K063655 is an FDA 510(k) premarket notification submitted by Dade Behring, Inc. for the device "DIMENSION VISTA; CER FLEX REAGENT CARTRIDGE, PROTEIN 1 CALIBRATOR, PROTEIN 1 CONTROL MEDIUM, PROTEIN 1 CONTROL HIGH". The FDA issued a decision of Substantially Equivalent on February 15, 2007. The device falls under product code CHN (Immunochemical, Ceruloplasmin), a Class II device regulated under 21 CFR 866.5210. Dade Behring, Inc. has at least 10 other 510(k) clearances on record.