510(k) K251289 ยท QVF Simple Point-Of-Care Device To Directly Detect Sars-Cov-2 Viral Targets From Clinical Specimens In Near-Patient Settings
WELLlife COVID-19 Antigen Test Rx
| Applicant | Guangzhou Wondfo Biotech Co., Ltd., Guangzhou, CN |
| Decision | Substantially Equivalent, Oct 22, 2025 |
| Received | Apr 25, 2025 |
| Type | Dual Track |
| FDA record | Open on fda.gov |
Recalls that name K251289
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.