GLUCO LAB AUTO CODING, MODEL IGM-0022

GLUCO LAB AUTO CODING, MODEL IGM-0022 is an FDA 510(k)-cleared medical device (K091157) 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 November 16, 2009. Regulation: 8.