510(k) K871328

DU PONT LEGIONELLA URINARY ANTIGEN - RIA KIT by E.I. Dupont DE Nemours & Co., Inc. — Product Code LHL

K871328 is an FDA 510(k) premarket notification submitted by E.I. Dupont DE Nemours & Co., Inc. for the device "DU PONT LEGIONELLA URINARY ANTIGEN - RIA KIT". The FDA issued a decision of Substantially Equivalent on September 2, 1987. The device falls under product code LHL (Reagents, Antibody, Legionella, Direct & Indirect Fluorescent), a Class II device regulated under 21 CFR 866.3300. E.I. Dupont DE Nemours & Co., Inc. has at least 10 other 510(k) clearances on record.