
Atlantic Antibodies
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IMMUNOGLOBULINS A,G,M,D,E IMMUNOLOGICAL TEST is an FDA 510(k)-cleared medical device (K861167) manufactured by Atlantic Antibodies. This device is classified under the Immunology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 24, 1986. Regulation: 8.