
Pointe Scientific, Inc.,
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DIAZO COLORIMETRY, BILIRUBIN is an FDA 510(k)-cleared medical device (K914873) 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 December 3, 1991. Regulation: 8.