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Bayer Corp.
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CLINITEK ATLAS PRO 12 REAGENT PAK SYSTEM is an FDA 510(k)-cleared medical device (K021428) manufactured by Bayer Corp.. 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 July 4, 2002. Regulation: 8.