510(k) K143312 ยท NJR Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test
Portrait GBS Assay
| Applicant | Great Basin Corporation, Salt Lake City UT, US |
| Decision | Substantially Equivalent, Apr 21, 2015 |
| Received | Nov 18, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K143312
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.