510(k) K252387 · QOF Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents
Simplexa COVID-19/ Flu A/B & RSV Direct (MOL4450); Simplexa COVID-19/ Flu A/B & RSV Positive Control Pack (MOL4460)
| Applicant | Diasorin Molecular, LLC, Cypress CA, US |
| Decision | Substantially Equivalent, Oct 30, 2025 |
| Received | Jul 31, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K252387
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.