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Immuno Concepts, N.A. , Ltd.
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AUTO I.D. JO-1, SCL-70 & PCNA POSITIVE CONTROL SERUM is an FDA 510(k)-cleared medical device (K030775) manufactured by Immuno Concepts, N.A. , Ltd.. This device is classified under the Immunology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 11, 2003. Regulation: 8.