GLYCOSCREEN GLYCOSYLATED HEMOGLOBIN ASSAY KIT

GLYCOSCREEN GLYCOSYLATED HEMOGLOBIN ASSAY KIT is an FDA 510(k)-cleared medical device (K864643) manufactured by Pacific Hemostasis. This device is classified under the Hematology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 27, 1987. Regulation: 8.