Clearance Summary
Thermo Scientific Oxoid Omadacycline Disc (30 ug) OMC30 received FDA 510(k) clearance under submission number K203336, sponsored by Oxoid Limited (Part of Thermo Fisher Scientific). The device was reviewed via the Traditional premarket notification pathway and assigned to the Microbiology review panel. The statutory decision date of record is 2022-09-15.
- Submission: K203336
- Applicant / Sponsor: Oxoid Limited (Part of Thermo Fisher Scientific)
- Clearance pathway: Traditional
- Review panel: Microbiology
- Device class: Class II
- Regulation citation: 21 CFR 866.1620
- Decision date: 2022-09-15
Classification & Regulation
This clearance is catalogued under FDA product code JTN and 21 CFR 866.1620, within the Microbiology review panel as a Class II device.