K231806
- 510(k) number
- K231806
- Device name
- Thermo Scientific Oxoid Rezafungin Disc (5 µg) RZF5
- Applicant
- Oxoid Limited (Part of Thermo Fisher Scientific) GB
- Product code
- JTN — Susceptibility Test Discs, Antimicrobial
- Decision date
- 2024-03-22
- Date received
- 2023-06-20
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Microbiology
This submission filed a 510(k) Statement rather than a Summary; no public summary is available from FDA.
Official FDA record: K231806
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.