VITROS CHEMISTRY PRODUCTS D%A1C REAGENT KIT, MODEL 680 2314; VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 18, MODEL 680 1702

VITROS CHEMISTRY PRODUCTS D%A1C REAGENT KIT, MODEL 680 2314; VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 18, MODEL 680 1702 is an FDA 510(k)-cleared medical device (K060650) manufactured by Ortho-Clinical Diagnostics, Inc.. This device is classified under the Hematology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 5, 2006. Regulation: 8.