IMMULITE 2000 SYSTEMS 3GALLERGY SPECIFIC IGE ASSAY

IMMULITE 2000 SYSTEMS 3GALLERGY SPECIFIC IGE ASSAY is an FDA 510(k)-cleared medical device (K132801) 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 May 27, 2014. Regulation: 8.