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Siemens Healthcare Diagnostics, Inc.
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IMMULITE 2000 3G ALLERGY SPECIFIC IGE ASSAY KIT MODEL L2KUN6 is an FDA 510(k)-cleared medical device (K093987) manufactured by Siemens Healthcare 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 27, 2011. Regulation: 8.