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Bayer Healthcare, LLC
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ASCENSIA BRIO BLOOD GLUCOSE MONITORING SYSTEM is an FDA 510(k)-cleared medical device (K043158) manufactured by Bayer Healthcare, LLC. 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 December 21, 2004. Regulation: 8.