510(k) K101460

LOCI 8 CALIBRATOR, MODEL KC 646 by Siemens Healthcare Diagnostics — Product Code JIX

K101460 is an FDA 510(k) premarket notification submitted by Siemens Healthcare Diagnostics for the device "LOCI 8 CALIBRATOR, MODEL KC 646". The FDA issued a decision of Substantially Equivalent on July 9, 2010. 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.