
Pointe Scientific, Inc.,
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LIQUID GLUCOSE (OXIDASE) REAGENT SET is an FDA 510(k)-cleared medical device (K970781) manufactured by Pointe Scientific, Inc.,. This device is classified under the Clinical Chemistry specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 20, 1997. Regulation: 8.