510(k) K241915 · QYT Over-The-Counter Covid-19 Antigen Test
CareSuperb COVID-19 Antigen Home Test
| Applicant | Access Bio, Inc., Somerset NJ, US |
| Decision | Substantially Equivalent, Jan 29, 2025 |
| Received | Jul 1, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K241915
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.