
Ortho-Clinical Diagnostics, Inc.
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VITROS CHEMISTRY PRODUCTS CI-SLIDES, CALIBRATOR KIT 2, MODEL(S) 844-5207, 166-2659 is an FDA 510(k)-cleared medical device (K071801) 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 July 19, 2007. Regulation: 8.