VITROS CHEMISTRY PRODUCTS NA + DT SLIDES, MODEL 153 2290 AND DT CALIBRATOR KIT, MODEL 195 7927

About This 510(k) Submission

K091861 is an FDA 510(k) clearance for the VITROS CHEMISTRY PRODUCTS NA + DT SLIDES, MODEL 153 2290 AND DT CALIBRATOR KIT, MODEL 195 7927, a Electrode, Ion Specific, Sodium (Class II — Special Controls, product code JGS), submitted by Ortho-Clinical Diagnostics, Inc. (Rochester, US). The FDA issued a Cleared decision on September 3, 2009, 76 days after receiving the submission on June 19, 2009. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1665.