INHALANT PROFILE-ALLERGEN-SPECIFIC IGE

INHALANT PROFILE-ALLERGEN-SPECIFIC IGE is an FDA 510(k)-cleared medical device (K823593) manufactured by Mast Immunosystems. This device is classified under the Immunology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 24, 1983. Regulation: 8.