
Ortho-Clinical Diagnostics, Inc.
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VITROS 5,1 FS CHEMISTRY SYSTEM WITH ENGEN LABORATORY AUTOMATION SYSTEM is an FDA 510(k)-cleared medical device (K063144) manufactured by Ortho-Clinical Diagnostics, Inc.. This device is classified under the Clinical Chemistry specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on November 12, 2006. Regulation: 8.