K251595
- 510(k) number
- K251595
- Device name
- COVID-19 Detect Rapid Self -Test
- Applicant
- InBios International, Inc. WA · US
- Product code
- QYT — Over-The-Counter Covid-19 Antigen Test
- Decision date
- 2025-10-12
- Date received
- 2025-05-27
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Microbiology
510(k) Summary (official FDA PDF): K251595.pdf
Official FDA record: K251595
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.