
Diazyme Laboratories
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Diazyme Fibrinogen Assay, Diazyme Fibrinogen Calibrator Set, Diazyme Fibrinogen Control Set is an FDA 510(k)-cleared medical device (K143470) manufactured by Diazyme Laboratories. This device is classified under the Hematology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 30, 2016. Regulation: 8.