510(k) K123321

DIMENSION CHEMISTRY III CALIBRATORY by Siemens Healthcare Diagnostics — Product Code JIX

K123321 is an FDA 510(k) premarket notification submitted by Siemens Healthcare Diagnostics for the device "DIMENSION CHEMISTRY III CALIBRATORY". The FDA issued a decision of Substantially Equivalent on February 15, 2013. The device falls under product code JIX (Calibrator, Multi-Analyte Mixture), a Class II device regulated under 21 CFR 862.1150. Siemens Healthcare Diagnostics has at least 10 other 510(k) clearances on record.