
Clinical Data, Inc.
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ENVOY 500 HDL; CHOLESTEROL REAGENT KIT (MODEL# 55301), CALIBRATOR KIT (MODEL# 55118) is an FDA 510(k)-cleared medical device (K071706) manufactured by Clinical Data, Inc.. This device is classified under the Clinical Chemistry specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on December 19, 2007. Regulation: 8.