510(k) K260184
- Device
- Onclarity Self-Collection Kit
- Applicant
- Becton, Dickinson and Company
- 510(k) number
- K260184
- Product code
- SEP
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2026-04-02
- Date received
- 2026-01-21
- Regulation
- 866.2920
- Classification name
- Device For Home Collection And Transport Of Vaginal Specimens By Lay Users For Use In An Approved Hpv Molecular Assay
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Related Records
Applicant Contact
- Contact
- Joseph Basore
- Address
- 7loveton Cir. Sparks MD US 21152 21152
FDA Registration Numbers
- 2032521
- 3011845225
- 3030907317
- 3027195609
- 3013160357
Source Documents
Other 510(k) Records For Product Code SEP
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| DEN240045 | Teal Wand | Teal Health, Inc. | 2025-05-09 |