510(k) K101456

ROCHE DIAGNOSTICS CALIBRATOR FOR AUTOMATED SYSTEMS, ROCHE DIAGNOSTICS CALIBRATOR CALIBRATOR FOR AUTOMATED SYSTEM by Roche Diagnostics — Product Code JIX

K101456 is an FDA 510(k) premarket notification submitted by Roche Diagnostics for the device "ROCHE DIAGNOSTICS CALIBRATOR FOR AUTOMATED SYSTEMS, ROCHE DIAGNOSTICS CALIBRATOR CALIBRATOR FOR AUTOMATED SYSTEM". The FDA issued a decision of Substantially Equivalent on September 8, 2010. 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.