510(k) K203429 ยท NJR Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test
Xpert GBS LB XC, GeneXpert Dx System, GeneXpert Infinity System
| Applicant | Cepheid, Sunnyvale CA, US |
| Decision | Substantially Equivalent, May 9, 2022 |
| Received | Nov 20, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K203429
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.