510(k) K251563 ยท SCA Multi-Analyte Respiratory Virus Antigen Detection Test
WELLlife Flu A&B Home Test; WELLlife Influenza A&B Test
| Applicant | Wondfo USA Co, Ltd., San Diego CA, US |
| Decision | Substantially Equivalent, Aug 20, 2025 |
| Received | May 22, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K251563
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.