510(k) K261347 ยท OCC Respiratory Virus Panel Nucleic Acid Assay System
DASH Flu A/B Test
| Applicant | Nuclein, LLC, Austin TX, US |
| Decision | Substantially Equivalent, Oct 21, 2026 |
| Received | Apr 24, 2026 |
| Type | Dual Track |
| FDA record | Open on fda.gov |
Recalls that name K261347
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.