
Dupont Medical Products
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ACA(R) DIGOXIN ANALYTICAL TEST PACK (DGN) is an FDA 510(k)-cleared medical device (K932732) manufactured by Dupont Medical Products. This device is classified under the Clinical Toxicology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 14, 1993. Regulation: 8.