510(k) K231381 ยท PQA Vaginitis And Bacterial Vaginosis Nucleic Acid Detection System
Xpert Xpress MVP; GeneXpert Xpress System
| Applicant | Cepheid, Sunnyvale CA, US |
| Decision | Substantially Equivalent, Oct 19, 2023 |
| Received | May 12, 2023 |
| Type | Dual Track |
| FDA record | Open on fda.gov |
Recalls that name K231381
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.