HEMOCUE HBA1C 501

HEMOCUE HBA1C 501 is an FDA 510(k)-cleared medical device (K121366) manufactured by Infopia Co, Ltd.. 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 6, 2012. Regulation: 8.