510(k) K181975

Thermo Scientific Oxoid Meropenem/Vaborbactam Disc (30µg) MEV30 by Oxoid Limited (Part of Thermo Fisher Scientific) — Product Code JTN

K181975 is an FDA 510(k) premarket notification submitted by Oxoid Limited (Part of Thermo Fisher Scientific) for the device "Thermo Scientific Oxoid Meropenem/Vaborbactam Disc (30µg) MEV30". The FDA issued a decision of Substantially Equivalent on September 27, 2018. 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.