GLYCO HB QUIK COLUMN PROCEDURE

GLYCO HB QUIK COLUMN PROCEDURE is an FDA 510(k)-cleared medical device (K823869) 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 January 31, 1983. Regulation: 8.