K260095
- 510(k) number
- K260095
- Device name
- Heal-Check Rapid COVID-19 Antigen Self-Test
- Applicant
- Healgen Scientific,, LLC TX · US
- Product code
- QYT — Over-The-Counter Covid-19 Antigen Test
- Decision date
- 2026-04-13
- Date received
- 2026-01-13
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Microbiology
PDFDownload 510(k) SummaryArchived here · 2.9 MB · U.S. public domain
Also available from FDA: K260095.pdf
Official FDA record: K260095
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.