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Bayer Corp.
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ADVIA 1650 GLUCOSE HEXOKINASE 11 ASSAY is an FDA 510(k)-cleared medical device (K011963) 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 November 19, 2001. Regulation: 8.