510(k) K222638 · NJR Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test
Xpert® Xpress GBS, GeneXpert® Dx System, GeneXpert® Infinity Systems
| Applicant | Cepheid, Sunnyvale CA, US |
| Decision | Substantially Equivalent, Sep 27, 2023 |
| Received | Sep 1, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K222638
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.