510(k) K072435

DIMENSION VISTA PROTEIN 3 CALIBRATOR, 3 CONTROL,1 CONTROL L, 1 CONTROL M, 1 CONTROL H by Dade Behring, Inc. — Product Code JIX

K072435 is an FDA 510(k) premarket notification submitted by Dade Behring, Inc. for the device "DIMENSION VISTA PROTEIN 3 CALIBRATOR, 3 CONTROL,1 CONTROL L, 1 CONTROL M, 1 CONTROL H". The FDA issued a decision of Substantially Equivalent on October 17, 2007. The device falls under product code JIX (Calibrator, Multi-Analyte Mixture), a Class II device regulated under 21 CFR 862.1150. Dade Behring, Inc. has at least 10 other 510(k) clearances on record.