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Nova Biomedical Corp.
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NOVA MAX PLUS GLOCOSE AND B-KETONE CONTROL SOLUTION-MID, HIGH is an FDA 510(k)-cleared medical device (K101633) manufactured by Nova Biomedical Corp.. This device is classified under the Clinical Chemistry specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on August 26, 2010. Regulation: 8.