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Bio-Rad Laboratories, Inc., Clinical Systems Divis
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VARIANT II TURBO HBA1C KIT-2.0 VARIANT II TURBO HEMOGLOBIN TESTING SYSTEM is an FDA 510(k)-cleared medical device (K122472) manufactured by Bio-Rad Laboratories, Inc., Clinical Systems Divis. This device is classified under the Hematology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 25, 2012. Regulation: 8.