K240728
- 510(k) number
- K240728
- Device name
- CorDx Tyfast COVID-19 Ag Rapid Test; CorDx COVID-19 Ag Test
- Applicant
- CorDx, Inc. CA · US
- Product code
- QYT — Over-The-Counter Covid-19 Antigen Test
- Decision date
- 2024-06-21
- Date received
- 2024-03-18
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Microbiology
PDFDownload 510(k) SummaryArchived here · 2.9 MB · U.S. public domain
Also available from FDA: K240728.pdf
Official FDA record: K240728
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.