K253882
- 510(k) number
- K253882
- Device name
- CorDx Tyfast COVID-19 Ag Rapid Test Rx
- Applicant
- CorDx, Inc. GA · US
- Product code
- QVF — Simple Point-Of-Care Device To Directly Detect Sars-
- Decision date
- 2026-06-01
- Date received
- 2025-12-04
- Decision
- Substantially Equivalent
- Clearance type
- Dual Track
- Advisory committee
- Microbiology
PDFDownload 510(k) SummaryArchived here · 2.8 MB · U.S. public domain
Also available from FDA: K253882.pdf
Official FDA record: K253882
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.