510(k) K232276

Thermo Scientific Oxoid Sulbactam/Durlobactam Disc (10/10 µg) SUD20 by Oxoid Limited (Part of Thermo Fisher Scientific) — Product Code JTN

K232276 is an FDA 510(k) premarket notification submitted by Oxoid Limited (Part of Thermo Fisher Scientific) for the device "Thermo Scientific Oxoid Sulbactam/Durlobactam Disc (10/10 µg) SUD20". The FDA issued a decision of Substantially Equivalent on October 6, 2023. The device falls under product code JTN (Susceptibility Test Discs, Antimicrobial), a Class II device regulated under 21 CFR 866.1620. Oxoid Limited (Part of Thermo Fisher Scientific) has at least 6 other 510(k) clearances on record.