
Immunotech Corp.
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OPTICLONE CD3/CD4 MONOCLONAL ANTIBODIES is an FDA 510(k)-cleared medical device (K950626) manufactured by Immunotech Corp.. This device is classified under the Hematology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 4, 1995. Regulation: 8.