K260184
- 510(k) number
- K260184
- Device name
- Onclarity Self-Collection Kit
- Applicant
- Becton, Dickinson and Company MD · US
- Product code
- SEP — Device For Home Collection And Transport Of Vaginal
- Decision date
- 2026-04-02
- Date received
- 2026-01-21
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Microbiology
PDFDownload 510(k) SummaryArchived here · 2.9 MB · U.S. public domain
Also available from FDA: K260184.pdf
Official FDA record: K260184
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.