K241317
- 510(k) number
- K241317
- Device name
- Wondfo 2019-nCoV Antigen Test (Lateral Flow Method)
- Applicant
- Guangzhou Wondfo Biotech Co., Ltd. CN
- Product code
- QYT — Over-The-Counter Covid-19 Antigen Test
- Decision date
- 2024-09-30
- Date received
- 2024-05-10
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Microbiology
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K241317.pdf
Official FDA record: K241317
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.