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Ortho-Clinical Diagnostics
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VITROS CHEMISTRY PRODUCTS BARB REAGENT; CALIBRATOR KIT 26; FS CALIBRATOR 1; DAT PERFORMANCE VERIFIERS is an FDA 510(k)-cleared medical device (K062165) manufactured by Ortho-Clinical Diagnostics. This device is classified under the Clinical Toxicology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 4, 2007. Regulation: 8.