510(k) K070971

MODIFICATION TO SENTINEL CLIN CHEM CAL by Sentinel Ch. Srl — Product Code JIX

K070971 is an FDA 510(k) premarket notification submitted by Sentinel Ch. Srl for the device "MODIFICATION TO SENTINEL CLIN CHEM CAL". The FDA issued a decision of Substantially Equivalent on May 23, 2007. The device falls under product code JIX (Calibrator, Multi-Analyte Mixture), a Class II device regulated under 21 CFR 862.1150. Sentinel Ch. Srl has at least 10 other 510(k) clearances on record.