510(k) K832985

TOBRAMYCIN ANALYTICAL TEST PACK-ACA by E.I. Dupont DE Nemours & Co., Inc. — Product Code KLB

K832985 is an FDA 510(k) premarket notification submitted by E.I. Dupont DE Nemours & Co., Inc. for the device "TOBRAMYCIN ANALYTICAL TEST PACK-ACA". The FDA issued a decision of Substantially Equivalent on October 27, 1983. The device falls under product code KLB (Radioimmunoassay, Tobramycin), a Class II device regulated under 21 CFR 862.3900. E.I. Dupont DE Nemours & Co., Inc. has at least 10 other 510(k) clearances on record.