
Nova Biomedical Corporation
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FOCUS BLOOD GLUCOSE MONITORING SYSTEM, FOCUS PRO BLOOD GLUCOSE MONITORING SYSTEM is an FDA 510(k)-cleared medical device (K131013) manufactured by Nova Biomedical Corporation. 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 October 16, 2013. Regulation: 8.