510(k) K251993 ยท PCH Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System
Panther Fusion GI Expanded Bacterial Assay
| Applicant | Hologic, Inc., San Diego CA, US |
| Decision | Substantially Equivalent, Sep 25, 2025 |
| Received | Jun 27, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K251993
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.