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Apex BioTechnology Corp.
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GLUCOSMART BLOOD GLUCOSE MONITORING SYSTEM is an FDA 510(k)-cleared medical device (K002624) manufactured by Apex BioTechnology 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 January 21, 2001. Regulation: 8.