VITROS CHEMISTRY PRODUCTS CO2 DT SLIDES; VITROS CHEMMISTRY PRODUCTS DT CALIBRATOR KIT, MODELS CO2 DT SLIDES, 172 0002;

About This 510(k) Submission

K093611 is an FDA 510(k) clearance for the VITROS CHEMISTRY PRODUCTS CO2 DT SLIDES; VITROS CHEMMISTRY PRODUCTS DT CALIBRATOR KIT, MODELS CO2 DT SLIDES, 172 0002;, a Enzymatic, Carbon-dioxide (Class II — Special Controls, product code KHS), submitted by Ortho-Clinical Diagnostics, Inc. (Rochester, US). The FDA issued a Cleared decision on April 15, 2010, 143 days after receiving the submission on November 23, 2009. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1160.