510(k) K243561 ยท SCA Multi-Analyte Respiratory Virus Antigen Detection Test
Nano-Check Influenza+COVID-19 Dual Test
| Applicant | Nano-Ditech Corporation, Cranbury NJ, US |
| Decision | Substantially Equivalent, Jun 17, 2025 |
| Received | Nov 18, 2024 |
| Type | Dual Track |
| FDA record | Open on fda.gov |
Recalls that name K243561
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.