510(k) K833379

LIDOCAINE ANALYTICAL TEST PACK ACA by E.I. Dupont DE Nemours & Co., Inc. — Product Code KLR

K833379 is an FDA 510(k) premarket notification submitted by E.I. Dupont DE Nemours & Co., Inc. for the device "LIDOCAINE ANALYTICAL TEST PACK ACA". The FDA issued a decision of Substantially Equivalent on December 27, 1983. The device falls under product code KLR (Enzyme Immunoassay, Lidocaine), a Class II device regulated under 21 CFR 862.3555. E.I. Dupont DE Nemours & Co., Inc. has at least 10 other 510(k) clearances on record.