K243405
- 510(k) number
- K243405
- Device name
- Xpert vanA
- Applicant
- Cepheid® CA · US
- Product code
- NIJ — System, Test, Genotypic Detection, Resistant Markers
- Decision date
- 2024-11-21
- Date received
- 2024-11-01
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Microbiology
510(k) Summary (official FDA PDF): K243405.pdf
Official FDA record: K243405
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.