
E.I. Dupont DE Nemours & Co., Inc.
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ACA IMMUNOGLOBULIN A/M CALIBRATORS is an FDA 510(k)-cleared medical device (K812633) manufactured by E.I. Dupont DE Nemours & Co., 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 September 28, 1981. Regulation: 8.