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

VITROS CHEMISTRY PRODUCTS K+DT SLIDES: VITROS CHEMISTRY PRODUCTS DT CALIBRATOR KIT, MODEL K+DT SLIDES: 153 2258 is an FDA 510(k)-cleared medical device (K083680) manufactured by Ortho-Clinical Diagnostics, Inc.. This device is classified under the Clinical Chemistry specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 26, 2009. Regulation: 8.