K251289
- 510(k) number
- K251289
- Device name
- WELLlife COVID-19 Antigen Test Rx
- Applicant
- Guangzhou Wondfo Biotech Co., Ltd. CN
- Product code
- QVF — Simple Point-Of-Care Device To Directly Detect Sars-
- Decision date
- 2025-10-22
- Date received
- 2025-04-25
- Decision
- Substantially Equivalent
- Clearance type
- Dual Track
- Advisory committee
- Microbiology
510(k) Summary (official FDA PDF): K251289.pdf
Official FDA record: K251289
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.