510(k) K250080 ยท QOF Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents
QIAstat-Dx Respiratory Panel Plus; QIAstat-Dx Respiratory Panel Mini
| Applicant | QIAGEN GmbH, Hilden, DE |
| Decision | Substantially Equivalent, Aug 27, 2025 |
| Received | Jan 13, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K250080
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.