510(k) K254194 ยท PAM Gram-Positive Bacteria And Their Resistance Markers
QIAstat-Dx BCID GPF Plus AMR Panel
| Applicant | QIAGEN GmbH, Hilden, DE |
| Decision | Substantially Equivalent, Aug 6, 2026 |
| Received | Dec 23, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K254194
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.