Panels › Microbiology › Product code SEP · Class 2
Device For Home Collection And Transport Of Vaginal Specimens By Lay Users For Use In An Approved Hpv Molecular Assay
Regulation 866.2920
1510(k)s in 12 months (2 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in SEP
| Company | 510(k)s | Recalls |
|---|---|---|
| Becton, Dickinson and Company | 1 | 0 |
| Teal Health, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 2, 2026 | K260184 | Onclarity Self-Collection Kit Becton, Dickinson and Company | SEP |
| May 9, 2025 | DEN240045 | Teal Wand Teal Health, Inc. | SEP |
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