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Elan Diagnostics
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ATAC DIRECT LDL REAGENT AND ATAC DIRECT LDL CALIBRATOR KITS is an FDA 510(k)-cleared medical device (K020575) manufactured by Elan Diagnostics. This device is classified under the Clinical Chemistry specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on April 11, 2002. Regulation: 8.