510(k) K243256 · SCA Multi-Analyte Respiratory Virus Antigen Detection Test
WELLlife COVID-19 / Influenza A&B Home Test; WELLlife COVID-19 / Influenza A&B AntigenTest
| Applicant | Wondfo USA Co, Ltd., San Diego CA, US |
| Decision | Substantially Equivalent, Jan 16, 2025 |
| Received | Oct 15, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K243256
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.