K260754
- 510(k) number
- K260754
- Device name
- Fastep COVID-19 Antigen Pen Home Test; Fastep COVID-19 Antigen Pen Test
- Applicant
- Assure Tech., LLC DE · US
- Product code
- QYT — Over-The-Counter Covid-19 Antigen Test
- Decision date
- 2026-06-05
- Date received
- 2026-03-09
- 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: K260754.pdf
Official FDA record: K260754
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.