510(k) K254032 ยท PCH Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System
QIAstat-Dx Gastrointestinal Panel 2; QIAstat-Dx GI Panel 2 Mini B&V; QIAstat-Dx GI Panel 2 Mini B
| Applicant | QIAGEN GmbH, Hilden, DE |
| Decision | Substantially Equivalent, Mar 9, 2026 |
| Received | Dec 16, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K254032
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.