K231795 is an FDA 510(k) clearance for the QuickVue COVID-19 Test. This device is classified as a Over-the-counter Covid-19 Antigen Test (Class II - Special Controls, product code QYT).
Submitted by Quidel Corporation (San Diego, US). The FDA issued a Cleared decision on March 22, 2024, 276 days after receiving the submission on June 20, 2023.
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 | K231795 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 20, 2023 |
| Decision Date | March 22, 2024 |
| Days to Decision | 276 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. |