510(k) K100060

EON 100 CHEMISTRY ANALYZER WITH ISE , MODEL 77105, BICARBONATE REAGENT, MODEL 77475 by Vital Diagnostics (Manufacturing) Ptyltd — Product Code KHS

K100060 is an FDA 510(k) premarket notification submitted by Vital Diagnostics (Manufacturing) Ptyltd for the device "EON 100 CHEMISTRY ANALYZER WITH ISE , MODEL 77105, BICARBONATE REAGENT, MODEL 77475". The FDA issued a decision of Substantially Equivalent on December 15, 2010. The device falls under product code KHS (Enzymatic, Carbon-Dioxide), a Class II device regulated under 21 CFR 862.1160. Vital Diagnostics (Manufacturing) Ptyltd has at least 4 other 510(k) clearances on record.