510(k) K852519

DUPONT ACA FIBRIN DEGRADATION PROD CLOTTING TUBE by E.I. Dupont DE Nemours & Co., Inc. — Product Code JCO

K852519 is an FDA 510(k) premarket notification submitted by E.I. Dupont DE Nemours & Co., Inc. for the device "DUPONT ACA FIBRIN DEGRADATION PROD CLOTTING TUBE". The FDA issued a decision of Substantially Equivalent on August 12, 1985. The device falls under product code JCO (Bothrops Atrox Reagent), a Class II device regulated under 21 CFR 864.8100. E.I. Dupont DE Nemours & Co., Inc. has at least 10 other 510(k) clearances on record.