PHADEXACT SERUM, ALLERGEN SPECIFIC IGE

PHADEXACT SERUM, ALLERGEN SPECIFIC IGE is an FDA 510(k)-cleared medical device (K842457) manufactured by Pharmacia, 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 July 1, 1984. Regulation: 8.