Clearance Summary
Thermo Scientific Oxoid Rezafungin Disc (5 µg) RZF5 received FDA 510(k) clearance under submission number K231806, 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 2024-03-22.
- Submission: K231806
- 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: 2024-03-22
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.