FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
WELLlife Flu A&B Home Test; WELLlife Influenza A&B Test
K Number: K251563
·
Decision Aug 20, 2025
Classifications
1
FEI Numbers
22
Registration Numbers
22
Same Product Code
10
Applicant Total
2
Review Days
90
Basic Information
- Device Name
- WELLlife Flu A&B Home Test; WELLlife Influenza A&B Test
- K Number
- K251563
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.3987
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Wondfo USA Co, Ltd.
- Date Received
- May 22, 2025
- Decision Date
- August 20, 2025
- Product Code
- SCA
- Advisory Committee
- Microbiology
- Review Advisory Committee
- MI
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| SCA | Multi-Analyte Respiratory Virus Antigen Detection Test | FDA class 2 | Microbiology |
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Other Clearances by Wondfo USA Co, Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K243256 | WELLlife COVID-19 / Influenza A&B Home Test; WELLlife COVID-19 / Influenza A&B AntigenTest | Jan 16, 2025 | Substantially Equivalent |