
Genzyme Corp.
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N-GENEOUS LDL CHOLESTEROL REAGENT, N-GENEOUS LDL CHOLESTEROL CALIBRATOR, GENZYME LDL CHOLESTEROL CONTROL SET is an FDA 510(k)-cleared medical device (K971573) manufactured by Genzyme Corp.. This device is classified under the Clinical Chemistry specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on June 17, 1997. Regulation: 8.