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Diagnostic Products Corp.
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IMMULITE 2000 ALLERGEN-SPECIFIC IGE AND SPECIFIC ALLERGENS, MDOEL L2KUN6 (600 TESTS) is an FDA 510(k)-cleared medical device (K013134) manufactured by Diagnostic Products Corp.. This device is classified under the Immunology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 14, 2001. Regulation: 8.