WELLlife COVID-19 / Influenza A&B Home Test; WELLlife COVID-19 / Influenza A&B AntigenTest— 510(k) K243256
Substantially EquivalentWondfo USA Co, Ltd.
FDA 510(k) clearance K243256 for WELLlife COVID-19 / Influenza A&B Home Test; WELLlife COVID-19 / Influenza A&B AntigenTest, Substantially Equivalent on 2025-01-16. Applicant: Wondfo USA Co, Ltd.. Device class: 2.
Clearance details
- Applicant
- Wondfo USA Co, Ltd.
- Product code
- Code SCA
- Device class
- Class 2
- Regulation
- 21 CFR 866.3987
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- San Diego, CA, US
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More clearances from Wondfo USA Co, Ltd.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.