510(k) K243730 · OZN C. Difficile Toxin Gene Amplification Assay
Xpert C. difficile/Epi
| Applicant | Cepheid®, Sunnyvale CA, US |
| Decision | Substantially Equivalent, Feb 28, 2025 |
| Received | Dec 3, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K243730
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.