RIGHTEST DIABETES MANAGEMENT SOFTWARE AND ADAPTER (EXISTING CLEARED K113007),RIGHTEST NEW ADAPTERS-3,GE DIABETES MANAGEM

RIGHTEST DIABETES MANAGEMENT SOFTWARE AND ADAPTER (EXISTING CLEARED K113007),RIGHTEST NEW ADAPTERS-3,GE DIABETES MANAGEM is an FDA 510(k)-cleared medical device (K133522) manufactured by Bionime Coporation. 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 16, 2014. Regulation: 8.