510(k) K251538 · SCA Multi-Analyte Respiratory Virus Antigen Detection Test
Status COVID-19/Flu A&B
| Applicant | Princeton BioMeditech Corp., Monmouth Junction NJ, US |
| Decision | Substantially Equivalent, Nov 14, 2025 |
| Received | May 19, 2025 |
| Type | Dual Track |
| FDA record | Open on fda.gov |
Recalls that name K251538
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.