GLYCO-JE,E CPMTRP;-NORMAL/ABNORMAL

GLYCO-JE,E CPMTRP;-NORMAL/ABNORMAL is an FDA 510(k)-cleared medical device (K833356) manufactured by Helena 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 November 2, 1983. Regulation: 8.