
Ortho-Clinical Diagnostics, Inc.
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VITROS CHEMISTRY PRODUCTS CA DT SLIDES AND DT CALIBRATOR KIT AND VITROS CA ASSAY is an FDA 510(k)-cleared medical device (K072443) 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 September 23, 2007. Regulation: 8.