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Ortho-Clinical Diagnostics
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THE VITROS 5,1 FS CHEMISTRY SYSTEM is an FDA 510(k)-cleared medical device (K041764) manufactured by Ortho-Clinical Diagnostics. This device is classified under the Hematology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 8, 2004. Regulation: 8.