
Bio-Rad Laboratories, Inc.
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VARIANT II HEMOGLOBIN A1C PROGRAM WITH MODELS 270-2101NU is an FDA 510(k)-cleared medical device (K070452) 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 May 6, 2007. Regulation: 8.