510(k) K230440 · QQX Respiratory Specimen Nucleic Acid Sars-Cov-2 Test
Xpert® Xpress CoV-2 plus
| Applicant | Cepheid®, Sunnyvale CA, US |
| Decision | Substantially Equivalent, Oct 13, 2023 |
| Received | Feb 21, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K230440
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.