510(k) K262168 ยท PEN Gram-Negative Bacteria And Associated Resistance Markers
QIAstat-Dx BCID GN Plus AMR Panel
| Applicant | QIAGEN GmbH, Hilden, DE |
| Decision | Substantially Equivalent, Sep 24, 2026 |
| Received | Jun 26, 2026 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K262168
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.