VITROS CHEMISTRY PRODUCTS K+DT SLIDES: VITROS CHEMISTRY PRODUCTS DT CALIBRATOR KIT, MODEL K+DT SLIDES: 153 2258

About This 510(k) Submission

K083680 is an FDA 510(k) clearance for the VITROS CHEMISTRY PRODUCTS K+DT SLIDES: VITROS CHEMISTRY PRODUCTS DT CALIBRATOR KIT, MODEL K+DT SLIDES: 153 2258, a Electrode, Ion Specific, Potassium (Class II — Special Controls, product code CEM), submitted by Ortho-Clinical Diagnostics, Inc. (Rochester, US). The FDA issued a Cleared decision on February 27, 2009, 77 days after receiving the submission on December 12, 2008. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1600.