510(k) K250273 ยท QVF Simple Point-Of-Care Device To Directly Detect Sars-Cov-2 Viral Targets From Clinical Specimens In Near-Patient Settings
BinaxNOW COVID-19 Ag Card
| Applicant | Abbott Diagnostics Scarborough, Inc., Scarborough ME, US |
| Decision | Substantially Equivalent, Jun 13, 2025 |
| Received | Jan 30, 2025 |
| Type | Dual Track |
| FDA record | Open on fda.gov |
Recalls that name K250273
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.