510(k) K843211

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

K843211 is an FDA 510(k) premarket notification submitted by E.I. Dupont DE Nemours & Co., Inc. for the device "AMIKACIN ANALYTICAL TEST PACK ACA". The FDA issued a decision of Substantially Equivalent on September 12, 1984. The device falls under product code KLQ (Radioimmunoassay, Amikacin), a Class II device regulated under 21 CFR 862.3035. E.I. Dupont DE Nemours & Co., Inc. has at least 10 other 510(k) clearances on record.