510(k) K133503 ยท NJR Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test
AMPLIVUE GBS ASSAY
| Applicant | Quidel Corporation, Athens OH, US |
| Decision | Substantially Equivalent, Dec 20, 2013 |
| Received | Nov 14, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K133503
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.