510(k) K103701

ADVIA CHEMISTRY LIQUID SPECIFIC PROTEIN CALIBRATORS by Siemens Healthcare Diagnostics, Inc. — Product Code JIX

K103701 is an FDA 510(k) premarket notification submitted by Siemens Healthcare Diagnostics, Inc. for the device "ADVIA CHEMISTRY LIQUID SPECIFIC PROTEIN CALIBRATORS". The FDA issued a decision of Substantially Equivalent on February 18, 2011. 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.