IMMULITE 2000 ALLERGEN-SPECIFIC IGE

IMMULITE 2000 ALLERGEN-SPECIFIC IGE is an FDA 510(k)-cleared medical device (K023152) manufactured by Diagnostic Products Corp.. This device is classified under the Immunology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 16, 2002. Regulation: 8.