510(k) K153365

ADVIA Chemistry Enzyme 1 Calibrator, ADVIA Chemistry Enzyme 2 Calibrator by Siemens Healthcare Diagnostics, Inc. — Product Code JIX

K153365 is an FDA 510(k) premarket notification submitted by Siemens Healthcare Diagnostics, Inc. for the device "ADVIA Chemistry Enzyme 1 Calibrator, ADVIA Chemistry Enzyme 2 Calibrator". The FDA issued a decision of Substantially Equivalent on December 18, 2015. The device falls under product code JIX (Calibrator, Multi-Analyte Mixture), a Class II device regulated under 21 CFR 862.1150. Siemens Healthcare Diagnostics, Inc. has at least 10 other 510(k) clearances on record.