Panels › Microbiology › Product code SIA · Class 2
Over-The-Counter Molecular Multi-Analyte Respiratory Virus Detection Test
Regulation 866.3984
1510(k)s in 12 months (1 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in SIA
| Company | 510(k)s | Recalls |
|---|---|---|
| Visby Medical, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 27, 2026 | K253971 | Visby Medical Flu and COVID-19 Test Visby Medical, Inc. | SIA |
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