510(k) K121539 ยท NJR Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test
XPERT GBS LB GENEXPERT DX SYSTEMS (GX-I, GX-IV) GENEXPERT DX SYSTEMS (GX-XVI) GENEXPERT INFINITY-48 SYSTEM (900-XXXX)
| Applicant | Cepheid, Sunnyvale CA, US |
| Decision | Substantially Equivalent, Nov 2, 2012 |
| Received | May 24, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K121539
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.