
More Diagnostics
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FIBRINOGEN CONTROL (HUMAN) LEVEL 1, 2, 3 is an FDA 510(k)-cleared medical device (K946193) 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 August 23, 1995. Regulation: 8.