HELENA GLYCOSYLATED HEMOGLOBIN QUIK METH

HELENA GLYCOSYLATED HEMOGLOBIN QUIK METH is an FDA 510(k)-cleared medical device (K800857) 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 September 25, 1980. Regulation: 8.