K243730
- 510(k) number
- K243730
- Device name
- Xpert C. difficile/Epi
- Applicant
- Cepheid® CA · US
- Product code
- OZN — C. Difficile Toxin Gene Amplification Assay
- Decision date
- 2025-02-28
- Date received
- 2024-12-03
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Microbiology
PDFDownload 510(k) SummaryArchived here · 0.7 MB · U.S. public domain
Also available from FDA: K243730.pdf
Official FDA record: K243730
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.