510(k) K103171

ELECSYS ANTI-TPO CALSET by Roche Diagnostics — Product Code JIX

K103171 is an FDA 510(k) premarket notification submitted by Roche Diagnostics for the device "ELECSYS ANTI-TPO CALSET". The FDA issued a decision of Substantially Equivalent on February 11, 2011. The device falls under product code JIX (Calibrator, Multi-Analyte Mixture), a Class II device regulated under 21 CFR 862.1150. Roche Diagnostics has at least 10 other 510(k) clearances on record.