510(k) K251721 ยท PCH Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System
Xpert GI Panel
| Applicant | Cepheid, Sunnyvale CA, US |
| Decision | Substantially Equivalent, Jan 16, 2026 |
| Received | Jun 4, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K251721
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.