510(k) K063322

DIMENSION VISTA TRF FLEX REAGENT CARTRIDGE, PROTEIN 1 CALIBRATOR PROTEIN 1 CONTROL L,CONTROL M, CONTROL H by Dade Behring, Inc. — Product Code DDG

K063322 is an FDA 510(k) premarket notification submitted by Dade Behring, Inc. for the device "DIMENSION VISTA TRF FLEX REAGENT CARTRIDGE, PROTEIN 1 CALIBRATOR PROTEIN 1 CONTROL L,CONTROL M, CONTROL H". The FDA issued a decision of Substantially Equivalent on January 24, 2007. The device falls under product code DDG (Transferrin, Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 866.5880. Dade Behring, Inc. has at least 10 other 510(k) clearances on record.