Hemoglobin A1c Assay, Hemoglobin A1c Calibrators, Hemoglobin A1c Controls

Hemoglobin A1c Assay, Hemoglobin A1c Calibrators, Hemoglobin A1c Controls is an FDA 510(k)-cleared medical device (K140654) manufactured by Abbott Laboratories. This device is classified under the Clinical Chemistry specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 21, 2015. Regulation: 8.