NORMAL AND ELEVATED CONTROL FOR GLYCO.

NORMAL AND ELEVATED CONTROL FOR GLYCO. is an FDA 510(k)-cleared medical device (K803186) manufactured by Applied Clinical Research Laboratories. 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 20, 1981. Regulation: 8.