
Pointe Scientific, Inc.,
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HEMOGLOBIN A1C REAGENT SET is an FDA 510(k)-cleared medical device (K031539) manufactured by Pointe Scientific, 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 August 5, 2003. Regulation: 8.