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Immuno Concepts, Inc.
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RELISA PR3-ANCA TEST SYSTEM FOR ANTIBODIES TO PROTEINASE 3, MODEL # 7096-16 is an FDA 510(k)-cleared medical device (K013283) manufactured by Immuno Concepts, Inc.. This device is classified under the Immunology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 13, 2001. Regulation: 8.