
Corning Medical & Scientific
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CORNING GLYCOSYLATED HEMOGLOBIN SET is an FDA 510(k)-cleared medical device (K791777) manufactured by Corning Medical & Scientific. This device is classified under the Hematology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 12, 1979. Regulation: 8.