
Elan Holdings, Inc.
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ATAC-PAK DIRECT HDL CHOLESTEROL REAGENT AND ATAC HDL-C CALIBRATOR KITS is an FDA 510(k)-cleared medical device (K991789) manufactured by Elan Holdings, Inc.. This device is classified under the Clinical Chemistry specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on July 8, 1999. Regulation: 8.