K241317 is an FDA 510(k) clearance for the Wondfo 2019-nCoV Antigen Test (Lateral Flow Method). This device is classified as a Over-the-counter Covid-19 Antigen Test (Class II - Special Controls, product code QYT).
Submitted by Guangzhou Wondfo Biotech Co., Ltd. (Guangzhou, CN). The FDA issued a Cleared decision on September 30, 2024, 143 days after receiving the submission on May 10, 2024.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3984. For The Rapid, Qualitative Detection Of Sars-cov-2 Virus Nucleocapsid Protein Antigen In Individuals 2 Years And Older..
| 510(k) Number | K241317 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 10, 2024 |
| Decision Date | September 30, 2024 |
| Days to Decision | 143 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Summary PDF |
| Product Code | QYT — Over-the-counter Covid-19 Antigen Test |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.3984 |
| Definition | For The Rapid, Qualitative Detection Of Sars-cov-2 Virus Nucleocapsid Protein Antigen In Individuals 2 Years And Older. |