
Cylex, Inc.
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IMMUKNOW-THE CYLEX IMMUNE CELLFUNCTION ASSAY is an FDA 510(k)-cleared medical device (K101911) manufactured by Cylex, Inc.. 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 17, 2010. Regulation: 8.