
Pointe Scientific, Inc.,
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FRUCTOSAMINE REAGENT SET, CALIBRATOR, AND CONTROL SET is an FDA 510(k)-cleared medical device (K993590) 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 December 20, 1999. Regulation: 8.