510(k) K840596

QUINIDINE ANALYTICAL TEST PACK by E.I. Dupont DE Nemours & Co., Inc. — Product Code LBZ

K840596 is an FDA 510(k) premarket notification submitted by E.I. Dupont DE Nemours & Co., Inc. for the device "QUINIDINE ANALYTICAL TEST PACK". The FDA issued a decision of Substantially Equivalent on April 4, 1984. The device falls under product code LBZ (Enzyme Immunoassay, Quinidine), a Class II device regulated under 21 CFR 862.3320. E.I. Dupont DE Nemours & Co., Inc. has at least 10 other 510(k) clearances on record.