510(k) K060540 ยท NJR Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test
XPERT, GENEXPERT DX SYSTEM
| Applicant | Cepheid, Sunnyvale CA, US |
| Decision | Substantially Equivalent, Jul 25, 2006 |
| Received | Mar 1, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K060540
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 12, 2008 | Cepheid Cepheid, Xpert GBS Assay Diagnostic Test Kit Part No: GXGBS-100N-10 (in foil pouch) for use with the GeneXpert DX System, Cepheid, Sunnyvale, CA 94089 Terminated |
NJR | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.