510(k) DEN240045
- Device
- Teal Wand
- Applicant
- Teal Health, Inc.
- 510(k) number
- DEN240045
- Product code
- SEP
- Decision
- Unknown (DENG)
- Decision date
- 2025-05-09
- Date received
- 2024-08-27
- 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
- Direct
- Third party reviewed
- N
Applicant Contact#
- Contact
- Trena Depel
- Address
- 1012 Torney Ave. San Francisco CA US 94129 94129
FDA Registration Numbers#
- 2032521
- 3027195609
- 3011845225
- 3013160357
- 3030907317
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code SEP#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K260184 | Onclarity™ Self-Collection Kit | Becton, Dickinson and Company | 2026-04-02 |