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Scantibodies Laboratory, Inc.
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ACTH IMMUNORADIOMETRIC (IRMA) ASSAY KIT, MODEL 3KG011 is an FDA 510(k)-cleared medical device (K050748) manufactured by Scantibodies Laboratory, Inc.. This device is classified under the Clinical Chemistry specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 19, 2005. Regulation: 8.