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Abbott Laboratories
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HEMOGLOBIN A1C, HEMOGLOBIN A1C CALIBRATORS, HEMOGLOBIN A1C CONTROLS is an FDA 510(k)-cleared medical device (K130255) 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 February 27, 2014. Regulation: 8.