Panels › Microbiology › Product code SEA · Class 2
Test For Detection Of Microorganism(S) Causing Sexually Transmitted Infections Performed By Lay Users
Regulation 866.3386
0510(k)s in 12 months (1 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in SEA
| Company | 510(k)s | Recalls |
|---|---|---|
| Visby Medical, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 28, 2025 | DEN240020 | Visby Medical Women's Sexual Health Test Visby Medical, Inc. | SEA |
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