510(k) K850058

DU PONT TOBRAMYCIN ASSAY REAGENTS by E.I. Dupont DE Nemours & Co., Inc. — Product Code LCR

K850058 is an FDA 510(k) premarket notification submitted by E.I. Dupont DE Nemours & Co., Inc. for the device "DU PONT TOBRAMYCIN ASSAY REAGENTS". The FDA issued a decision of Substantially Equivalent on Jan 18, 1985. The device falls under product code LCR (Fluorescent Immunoassay, Tobramycin), a Class II device regulated under 21 CFR 862.3900. E.I. Dupont DE Nemours & Co., Inc. has 252 other 510(k) clearances on record.