NOVA MAX MINI BLOOD GLUCOSE AND B-KETONE MONITOR

NOVA MAX MINI BLOOD GLUCOSE AND B-KETONE MONITOR is an FDA 510(k)-cleared medical device (K122688) 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 April 3, 2013. Regulation: 8.