510(k) K170557 ยท NJR Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test
GenePOC GBS LB
| Applicant | Genepoc, Inc., Quebec, CA |
| Decision | Substantially Equivalent, May 25, 2017 |
| Received | Feb 24, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K170557
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.