
More Diagnostics
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FIBRIN(OGEN) FDP CONTROL LEVEL 1 & LEVEL 2 is an FDA 510(k)-cleared medical device (K932657) manufactured by More Diagnostics. 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 1, 1993. Regulation: 8.