HEMOGLOBIN A1C BY COLUMN TEST (MICRO A1C)

HEMOGLOBIN A1C BY COLUMN TEST (MICRO A1C) is an FDA 510(k)-cleared medical device (K862371) 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 September 15, 1986. Regulation: 8.