K251563
- 510(k) number
- K251563
- Device name
- WELLlife Flu A&B Home Test; WELLlife Influenza A&B Test
- Applicant
- Wondfo USA Co, Ltd. CA · US
- Product code
- SCA — Multi-Analyte Respiratory Virus Antigen Detection Te
- Decision date
- 2025-08-20
- Date received
- 2025-05-22
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Microbiology
PDFDownload 510(k) SummaryArchived here · 2.7 MB · U.S. public domain
Also available from FDA: K251563.pdf
Official FDA record: K251563
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.