DIAMAT GLYCOSLATED HEMOGLOBIN ANALYZER SYSTEM

DIAMAT GLYCOSLATED HEMOGLOBIN ANALYZER SYSTEM is an FDA 510(k)-cleared medical device (K851636) manufactured by Bio-Rad. This device is classified under the Hematology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 29, 1985. Regulation: 8.