510(k) K221160 ยท PQA Vaginitis And Bacterial Vaginosis Nucleic Acid Detection System
Xpert Xpress MVP, GeneXpert Dx System, GeneXpert Infinity System
| Applicant | Cepheid, Sunnyvale CA, US |
| Decision | Substantially Equivalent, Jun 7, 2022 |
| Received | Apr 21, 2022 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K221160
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.