BLOOD GLUCOSE MONITORING SYSTEM (GLUCOSE OXIDASE)

BLOOD GLUCOSE MONITORING SYSTEM (GLUCOSE OXIDASE) is an FDA 510(k)-cleared medical device (K113636) manufactured by Philosys Co., Ltd.. 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 March 7, 2013. Regulation: 8.