510(k) K812625

ACA PLASMINOGEN TEST PACK by E.I. Dupont DE Nemours & Co., Inc. — Product Code DDX

K812625 is an FDA 510(k) premarket notification submitted by E.I. Dupont DE Nemours & Co., Inc. for the device "ACA PLASMINOGEN TEST PACK". The FDA issued a decision of Substantially Equivalent on September 29, 1981. The device falls under product code DDX (Plasminogen, Antigen, Antiserum, Control), a Class I device regulated under 21 CFR 866.5715. E.I. Dupont DE Nemours & Co., Inc. has at least 10 other 510(k) clearances on record.