510(k) K251868 ยท PCH Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System
Panther Fusion GI Bacterial Assay
| Applicant | Hologic, San Diego CA, US |
| Decision | Substantially Equivalent, Sep 25, 2025 |
| Received | Jun 18, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K251868
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.