BIONIME RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM, MODEL GM650

BIONIME RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM, MODEL GM650 is an FDA 510(k)-cleared medical device (K120423) manufactured by Bionime 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 August 2, 2012. Regulation: 8.