510(k) K251604 ยท SCA Multi-Analyte Respiratory Virus Antigen Detection Test
CareSuperb COVID-19/Flu A&B Antigen Combo Home Test
| Applicant | Access Bio, Inc., Monroe Township NJ, US |
| Decision | Substantially Equivalent, Aug 22, 2025 |
| Received | May 27, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K251604
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.