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Bayer Healthcare
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ASCENSIA CONTOUR BLOOD GLUCOSE METER, MODEL 7151; REAGENT STRIP, MODEL 7080 is an FDA 510(k)-cleared medical device (K062058) manufactured by Bayer Healthcare. 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 September 10, 2006. Regulation: 8.