Great Basin Toxigenic C. difficile Direct Test (CDF2)— 510(k) K232092
Substantially EquivalentVela Operations USA
FDA 510(k) clearance K232092 for Great Basin Toxigenic C. difficile Direct Test (CDF2), Substantially Equivalent on 2023-11-14. Applicant: Vela Operations USA.
Clearance details
- Applicant
- Vela Operations USA
- Product code
- Code OZN
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Salt Lake City, UT, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.