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Bio-Rad Laboratories, Inc.
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VARIANT II TURBO HEMOGLOBIN A1C PROGRAM, HEMOGLOBIN TESTING SYSTEM WITH CDM 4.0 is an FDA 510(k)-cleared medical device (K063400) manufactured by Bio-Rad Laboratories, 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 November 30, 2006. Regulation: 8.