GLUCOPHONE BLOOD GLUCOSE TEST SYSTEM, MODEL IGM-0025

GLUCOPHONE BLOOD GLUCOSE TEST SYSTEM, MODEL IGM-0025 is an FDA 510(k)-cleared medical device (K091168) manufactured by Infopia 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 May 26, 2010. Regulation: 8.