510(k) K260754 ยท QYT Over-The-Counter Covid-19 Antigen Test
Fastep COVID-19 Antigen Pen Home Test; Fastep COVID-19 Antigen Pen Test
| Applicant | Assure Tech., LLC, Wilmington DE, US |
| Decision | Substantially Equivalent, Jun 5, 2026 |
| Received | Mar 9, 2026 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K260754
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.