Clearance Summary
Great Basin Toxigenic C. difficile Direct Test (CDF2) received FDA 510(k) clearance under submission number K232092, sponsored by Vela Operations USA. The device was reviewed via the Traditional premarket notification pathway and assigned to the Microbiology review panel. The statutory decision date of record is 2023-11-14.
- Submission: K232092
- Applicant / Sponsor: Vela Operations USA
- Clearance pathway: Traditional
- Review panel: Microbiology
- Device class: Class II
- Regulation citation: 21 CFR 866.3130
- Decision date: 2023-11-14
Classification & Regulation
This clearance is catalogued under FDA product code OZN and 21 CFR 866.3130, within the Microbiology review panel as a Class II device.