510(k) K062948 ยท NJR Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test
SMART GBS AND SMARTCYCLE DX SYSTEM AND SOFTWARE, VERSION 1.7B
| Applicant | Cepheid, Sunnyvale CA, US |
| Decision | Substantially Equivalent, Dec 8, 2006 |
| Received | Sep 28, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K062948
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.