Thermo Scientific Oxoid Rezafungin Disc (5 µg) RZF5
FDA 510(k) clearance K231806 · decided 2024-03-22
Clearance details
- K-number
- K231806
- Device name
- Thermo Scientific Oxoid Rezafungin Disc (5 µg) RZF5
- Applicant
- Oxoid Limited (Part of Thermo Fisher Scientific)
- Decision
- Substantially Equivalent
- Date received
- 2023-06-20
- Decision date
- 2024-03-22
- Days to decision
- 276 days
- Clearance type
- Traditional
- Product code
- JTN
- Device class
- 2
- Regulation number
- 866.1620
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Basingstoke, GB
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.