510(k) K133330

C.F.A.S. PROTEINS, C.F.A.S. PAC, PRECICONTROL CLINCHEM MULTI 1 & 2, PRECINORM PROTEIN & PRECIPATH PROTEIN by Roche Diagnostics — Product Code JIX

K133330 is an FDA 510(k) premarket notification submitted by Roche Diagnostics for the device "C.F.A.S. PROTEINS, C.F.A.S. PAC, PRECICONTROL CLINCHEM MULTI 1 & 2, PRECINORM PROTEIN & PRECIPATH PROTEIN". The FDA issued a decision of Substantially Equivalent on November 26, 2013. The device falls under product code JIX (Calibrator, Multi-Analyte Mixture), a Class II device regulated under 21 CFR 862.1150. Roche Diagnostics has at least 10 other 510(k) clearances on record.