
E.I. Dupont DE Nemours & Co., Inc.
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DU PONT ACA PLUS IMMUNOASSAY SYSTEM TSH CALIBRATOR is an FDA 510(k)-cleared medical device (K922698) manufactured by E.I. Dupont DE Nemours & Co., Inc.. This device is classified under the Clinical Chemistry specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 8, 1992. Regulation: 8.