510(k) K203336

Thermo Scientific Oxoid Omadacycline Disc (30 ug) OMC30 by Oxoid Limited (Part of Thermo Fisher Scientific) — Product Code JTN

K203336 is an FDA 510(k) premarket notification submitted by Oxoid Limited (Part of Thermo Fisher Scientific) for the device "Thermo Scientific Oxoid Omadacycline Disc (30 ug) OMC30". The FDA issued a decision of Substantially Equivalent on September 15, 2022. 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.