ABBOTT VISION(TM) GLYCATED HB

ABBOTT VISION(TM) GLYCATED HB is an FDA 510(k)-cleared medical device (K904027) manufactured by Abbott 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 February 6, 1991. Regulation: 8.