Clearance Summary
Onclarity Self-Collection Kit received FDA 510(k) clearance under submission number K260184, sponsored by Becton, Dickinson and Company. The device was reviewed via the Traditional premarket notification pathway and assigned to the Microbiology review panel. The statutory decision date of record is 2026-04-02.
- Submission: K260184
- Applicant / Sponsor: Becton, Dickinson and Company
- Clearance pathway: Traditional
- Review panel: Microbiology
- Device class: Class II
- Regulation citation: 21 CFR 866.2920
- Decision date: 2026-04-02
Classification & Regulation
This clearance is catalogued under FDA product code SEP and 21 CFR 866.2920, within the Microbiology review panel as a Class II device.