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Diagnostic Products Corp.
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IMMULITE RUBELLA IGM,LKRM1, LKRM2, IMMULITE 2000 RUBELLA IGM, MODEL L2KRM2, L2KRM6 is an FDA 510(k)-cleared medical device (K012077) manufactured by Diagnostic Products Corp.. This device is classified under the Microbiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 9, 2002. Regulation: 8.