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Astoria-Pacific, Inc.
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ASTORIA-PACIFIC SPOTCHECK BIOTINIDASE MICROPLATE REAGENT KIT is an FDA 510(k)-cleared medical device (K080294) manufactured by Astoria-Pacific, 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 November 3, 2008. Regulation: 8.