510(k) K261781

Thermo Scientific Oxoid Cefepime/Zidebactam Disc (30/30 µg) FPZ60 by Thermo Fisher Scientific (Oxoid Ltd.) — Product Code JTN

K261781 is an FDA 510(k) premarket notification submitted by Thermo Fisher Scientific (Oxoid Ltd.) for the device "Thermo Scientific Oxoid Cefepime/Zidebactam Disc (30/30 µg) FPZ60". The FDA issued a decision of Substantially Equivalent on July 24, 2026. The device falls under product code JTN (Susceptibility Test Discs, Antimicrobial), a Class II device regulated under 21 CFR 866.1620. Thermo Fisher Scientific (Oxoid Ltd.) has at least 2 other 510(k) clearances on record.