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Euroimmun US
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EUROIMMUN ANTI-LKM-1 ELISA(LGG) is an FDA 510(k)-cleared medical device (K112223) manufactured by Euroimmun US. This device is classified under the Immunology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 10, 2012. Regulation: 8.