
Infopia Co, Ltd.
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CLOVER A1C/GLYCOSYLATED HEMOGLOBIN MONITOR & BLOOD GLUCOSE MONITOR, MODEL IGM-0023 is an FDA 510(k)-cleared medical device (K082275) manufactured by Infopia Co, Ltd.. This device is classified under the Hematology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 13, 2010. Regulation: 8.