
Beckman Coulter, Inc.
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UNICEL DXC SYNCHRON SYSTEMS HEMOGLOBIN A1C3 (HBA1C3) REAGENT is an FDA 510(k)-cleared medical device (K140829) manufactured by Beckman Coulter, Inc.. This device is classified under the Hematology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 13, 2014. Regulation: 8.