510(k) K212213 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, Feb 9, 2022 |
| Received | Jul 15, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K212213
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.