510(k) K851228

GENERAL DIAGNOSTICS AUGMENTIN 30MCG SUSCEP DISK by Warner-Lambert Co. — Product Code JTN

K851228 is an FDA 510(k) premarket notification submitted by Warner-Lambert Co. for the device "GENERAL DIAGNOSTICS AUGMENTIN 30MCG SUSCEP DISK". The FDA issued a decision of Substantially Equivalent on April 24, 1985. The device falls under product code JTN (Susceptibility Test Discs, Antimicrobial), a Class II device regulated under 21 CFR 866.1620. Warner-Lambert Co. has at least 10 other 510(k) clearances on record.