Documento fuente o registro público
FDA 510(k) K251289 — WELLlife COVID-19 Antigen Test Rx
FDA 510(k) index record K251289. Device: WELLlife COVID-19 Antigen Test Rx. Applicant as listed: Guangzhou Wondfo Biotech Co., Ltd.. Decision date: 2025-10-22.
Fuente
"device_name": "WELLlife COVID-19 Antigen Test Rx"
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Automated FDA record verification
2026-10-20
2026-10-24
professional use
FDA 510(k) public index record K251289.
Device name: WELLlife COVID-19 Antigen Test Rx. Applicant as listed: Guangzhou Wondfo Biotech Co., Ltd..
Decision date: 2025-10-22. Decision wording: Substantially Equivalent.
Product code: QVF. Regulation: 21 CFR 866.3982. Medical specialty: Microbiology.
This page reproduces regulator index metadata. The applicant field identifies the submitter and is not a manufacturer identity check. Consult the original FDA record for the decision and associated documents; this index does not verify current commercial availability or clinical performance.
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