Source document or public record
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.
Source
"device_name": "WELLlife COVID-19 / Influenza A&B Home Test; WELLlife COVID-19 / Influenza A&B AntigenTest"
This entry describes what the document covers; the document itself is the authority. Listing it is not agreement with its conclusions.
Review and references
Automated FDA record verification
2026-10-20
2026-10-20
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.
Interested in these solutions?
Submit a sourcing request with the assays, volumes, and timeline of your own project.