K232092
- 510(k) number
- K232092
- Device name
- Great Basin Toxigenic C. difficile Direct Test (CDF2)
- Applicant
- Vela Operations USA UT · US
- Product code
- OZN — C. Difficile Toxin Gene Amplification Assay
- Decision date
- 2023-11-14
- Date received
- 2023-07-13
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Microbiology
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K232092.pdf
Official FDA record: K232092
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.