510(k) K173725 ยท NJR Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test
NeuMoDx GBS Assay
| Applicant | Neumodx Molecular, Inc., Ann Arbor MI, US |
| Decision | Substantially Equivalent, Jun 26, 2018 |
| Received | Dec 5, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K173725
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.