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Fred Hutchinson Cancer Research Center
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FRED HUTCHINSON CANCER RESEARCH CENTER ENZYME ANTI-SR PROTEIN ANTIBODY TEST is an FDA 510(k)-cleared medical device (K013263) manufactured by Fred Hutchinson Cancer Research Center. This device is classified under the Immunology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 28, 2002. Regulation: 8.