Thermo Scientific Oxoid Rezafungin Disc (5 µg) RZF5— 510(k) K231806
Substantially EquivalentOxoid Limited (Part of Thermo Fisher Scientific)
FDA 510(k) clearance K231806 for Thermo Scientific Oxoid Rezafungin Disc (5 µg) RZF5, Substantially Equivalent on 2024-03-22. Applicant: Oxoid Limited (Part of Thermo Fisher Scientific). Device class: 2.
Clearance details
- Applicant
- Oxoid Limited (Part of Thermo Fisher Scientific)
- Product code
- Code JTN
- Device class
- Class 2
- Regulation
- 21 CFR 866.1620
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Basingstoke, GB
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Data sourced from openFDA. This site is unofficial and independent of the FDA.