IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT

IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT is an FDA 510(k)-cleared medical device (K091289) 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 August 5, 2009. Regulation: 8.