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Elan Holdings, Inc.
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ATAC PAK BUN REAGENT AND ATAC CALIBRATOR KITS is an FDA 510(k)-cleared medical device (K000958) manufactured by Elan Holdings, Inc.. This device is classified under the Clinical Chemistry specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 23, 2000. Regulation: 8.