ATAC PAK CHOLESTEROL REAGENT AND ATAC CALLIBRATOR KITS

ATAC PAK CHOLESTEROL REAGENT AND ATAC CALLIBRATOR KITS is an FDA 510(k)-cleared medical device (K000900) 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 May 1, 2000. Regulation: 8.