510(k) K173250 ยท NJR Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test
Solana GBS Assay
| Applicant | Quidel Corporation, Athens OH, US |
| Decision | Substantially Equivalent, Dec 21, 2017 |
| Received | Oct 10, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K173250
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.