K251916
- 510(k) number
- K251916
- Device name
- GenBody COVID-19 Ag Home Test
- Applicant
- Genbody.Inc. KR
- Product code
- QYT — Over-The-Counter Covid-19 Antigen Test
- Decision date
- 2026-03-13
- Date received
- 2025-06-23
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Microbiology
PDFDownload 510(k) SummaryArchived here · 2.8 MB · U.S. public domain
Also available from FDA: K251916.pdf
Official FDA record: K251916
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.