K251753
- 510(k) number
- K251753
- Device name
- GenaCheck COVID-19 Rapid Self-Test
- Applicant
- Genabio Diagnostics, Inc. MA · US
- Product code
- QYT — Over-The-Counter Covid-19 Antigen Test
- Decision date
- 2025-09-05
- Date received
- 2025-06-09
- 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: K251753.pdf
Official FDA record: K251753
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.