IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT, MODEL L2KUN6

IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT, MODEL L2KUN6 is an FDA 510(k)-cleared medical device (K091984) manufactured by Siemens Medical Solutions 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 October 27, 2009. Regulation: 8.