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Vital Scientific N.V.
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FIBRON-1, FIBRON-4, QUIKCOAG, FIBRON is an FDA 510(k)-cleared medical device (K021976) manufactured by Vital Scientific N.V.. This device is classified under the Hematology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 24, 2002. Regulation: 8.