510(k) K063351

DIMENSION VISTA CYSC FLEX REAGENT CARTRIDGE, PROTEIN 3 CALIBRATOR AND CYSTATIN CONTROL LOW AND HIGH by Dade Behring, Inc. — Product Code NDY

K063351 is an FDA 510(k) premarket notification submitted by Dade Behring, Inc. for the device "DIMENSION VISTA CYSC FLEX REAGENT CARTRIDGE, PROTEIN 3 CALIBRATOR AND CYSTATIN CONTROL LOW AND HIGH". The FDA issued a decision of Substantially Equivalent on January 22, 2007. The device falls under product code NDY (Test, Cystatin C), a Class II device regulated under 21 CFR 862.1225. Dade Behring, Inc. has at least 10 other 510(k) clearances on record.