510(k) K243518 · QYT Over-The-Counter Covid-19 Antigen Test
BinaxNOW COVID-19 Antigen Self Test
| Applicant | Abbott Diagnostics Scarborough, Inc., Scarborough ME, US |
| Decision | Substantially Equivalent, Feb 11, 2025 |
| Received | Nov 13, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K243518
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.