510(k) K831210

GENTAMICIN TEST PACK-ACA by E.I. Dupont DE Nemours & Co., Inc. — Product Code DJB

K831210 is an FDA 510(k) premarket notification submitted by E.I. Dupont DE Nemours & Co., Inc. for the device "GENTAMICIN TEST PACK-ACA". The FDA issued a decision of Substantially Equivalent on May 25, 1983. The device falls under product code DJB (Radioimmunoassay, Gentamicin (125-I), Second Antibody Sep.), a Class II device regulated under 21 CFR 862.3450. E.I. Dupont DE Nemours & Co., Inc. has at least 10 other 510(k) clearances on record.