K231795
- 510(k) number
- K231795
- Device name
- QuickVue COVID-19 Test
- Applicant
- Quidel Corporation CA · US
- Product code
- QYT — Over-The-Counter Covid-19 Antigen Test
- Decision date
- 2024-03-22
- Date received
- 2023-06-20
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Microbiology
PDFDownload 510(k) SummaryArchived here · 2.7 MB · U.S. public domain
Also available from FDA: K231795.pdf
Official FDA record: K231795
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.