
Bio-Rad
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VARIANT(TM) HEMOGLOBIN A 1C PROGRAM is an FDA 510(k)-cleared medical device (K926469) manufactured by Bio-Rad. This device is classified under the Hematology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 28, 1993. Regulation: 8.