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Bio-Rad Laboratories, Inc.
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VARIANT II TURBO HBA1C KIT KIT-20 AND WASH/DILUENT SOLUTION SET, MODELS 270-2455, 270-2730 is an FDA 510(k)-cleared medical device (K090699) 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 July 26, 2009. Regulation: 8.