
Bio-Rad Laboratories, Inc.
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VARIANT II TURBO HbA1c Kit - 2.0 is an FDA 510(k)-cleared medical device (K142448) manufactured by Bio-Rad Laboratories, Inc.. 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 March 23, 2015. Regulation: 8.