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Siemens Healthcare Diagnostics
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IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT is an FDA 510(k)-cleared medical device (K090257) manufactured by Siemens Healthcare Diagnostics. This device is classified under the Immunology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 25, 2009. Regulation: 8.