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Immco Diagnostics, Inc.
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ANIT-ENA ANTIBODY TEST [SS-B (LA)] is an FDA 510(k)-cleared medical device (K920384) manufactured by Immco Diagnostics, 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 March 29, 1992. Regulation: 8.