510(k) DEN240045
DEN240045 is an FDA 510(k) premarket notification submitted by Teal Health, Inc. for the device "Teal Wand". The FDA issued a decision of De Novo Granted on May 9, 2025. The device falls under product code SEP (Device For Home Collection And Transport Of Vaginal Specimens By Lay Users For Use In An Approved Hpv Molecular Assay), a Class II device regulated under 21 CFR 866.2920.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- May 9, 2025
- Date Received
- August 27, 2024
- Clearance Type
- Direct
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Device For Home Collection And Transport Of Vaginal Specimens By Lay Users For Use In An Approved Hpv Molecular Assay
- Device Class
- Class II
- Regulation Number
- 866.2920
- Review Panel
- MI
- Submission Type
A device for home collection and transport of vaginal specimens by lay users for HPV testing is a device intended for use by lay users in home settings or similar environments for the collection and transportation of vaginal specimens for testing using an approved HPV molecular assay with which the device has been validated.