510(k) K231806
- Device
- Thermo Scientific Oxoid Rezafungin Disc (5 µg) RZF5
- Applicant
- Oxoid Limited (Part of Thermo Fisher Scientific)
- 510(k) number
- K231806
- Product code
- JTN
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2024-03-22
- Date received
- 2023-06-20
- Regulation
- 866.1620
- Classification name
- Susceptibility Test Discs, Antimicrobial
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Related Records
Applicant Contact
- Contact
- Amie Lovatt
- Address
- Wade Rd. Basingstoke GB RG24 8PW RG24 8PW
FDA Registration Numbers
- 3004111573
- 2030652
- 3035367039
- 1119779
- 8020667
- 8010096
- 2022807
- 3013661582
- 2032112
- 3012389632
- 2647876
Source Documents
510(k) summary PDF not indicated by FDA
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