510(k) K891093

ACA (R) DIGITOXIN CALIBRATOR by E.I. Dupont DE Nemours & Co., Inc. — Product Code DCJ

K891093 is an FDA 510(k) premarket notification submitted by E.I. Dupont DE Nemours & Co., Inc. for the device "ACA (R) DIGITOXIN CALIBRATOR". The FDA issued a decision of Substantially Equivalent on April 26, 1989. The device falls under product code DCJ (Beta-Globulin, Antigen, Antiserum, Control), a Class I device regulated under 21 CFR 866.5160. E.I. Dupont DE Nemours & Co., Inc. has at least 10 other 510(k) clearances on record.