Documento fuente o registro público
FDA 510(k) K243256 — WELLlife COVID-19 / Influenza A&B Home Test; WELLlife COVID-19 / Influenza A&B AntigenTest
FDA 510(k) index record K243256. Device: WELLlife COVID-19 / Influenza A&B Home Test; WELLlife COVID-19 / Influenza A&B AntigenTest. Applicant as listed: Wondfo USA Co, Ltd.. Decision date: 2025-01-16.
Fuente
"device_name": "WELLlife COVID-19 / Influenza A&B Home Test; WELLlife COVID-19 / Influenza A&B AntigenTest"
Esta entrada describe lo que cubre el documento; el propio documento es la autoridad. Incluirlo no implica estar de acuerdo con sus conclusiones.
Review and references
Automated FDA record verification
2026-10-20
2026-10-25
professional use
FDA 510(k) public index record K243256.
Device name: WELLlife COVID-19 / Influenza A&B Home Test; WELLlife COVID-19 / Influenza A&B AntigenTest. Applicant as listed: Wondfo USA Co, Ltd..
Decision date: 2025-01-16. Decision wording: Substantially Equivalent.
Product code: SCA. Regulation: 21 CFR 866.3987. 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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