510(k) K092113

STA - FREE PS CALIBRATOR by Diagnostica Stago, Inc. — Product Code JIX

K092113 is an FDA 510(k) premarket notification submitted by Diagnostica Stago, Inc. for the device "STA - FREE PS CALIBRATOR". The FDA issued a decision of Substantially Equivalent on November 13, 2009. The device falls under product code JIX (Calibrator, Multi-Analyte Mixture), a Class II device regulated under 21 CFR 862.1150. Diagnostica Stago, Inc. has at least 10 other 510(k) clearances on record.