GLYCOSYLATED HEMOGLOBIN-SMC COLUMN

GLYCOSYLATED HEMOGLOBIN-SMC COLUMN is an FDA 510(k)-cleared medical device (K802233) 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 October 9, 1980. Regulation: 8.