510(k) K250995 · QOF Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents
Xpert Xpress CoV-2/Flu/RSV plus
| Applicant | Cepheid®, Sunnyvale CA, US |
| Decision | Substantially Equivalent, May 1, 2025 |
| Received | Apr 1, 2025 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K250995
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.