K241313
- 510(k) number
- K241313
- Device name
- OHC COVID-19 Antigen Self Test
- Applicant
- Osang, LLC CA · US
- Product code
- QYT — Over-The-Counter Covid-19 Antigen Test
- Decision date
- 2025-05-30
- Date received
- 2024-05-09
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Microbiology
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K241313.pdf
Official FDA record: K241313
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.