510(k) K182467 ยท NJR Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test
Simplexa GBS Direct, Simplexa GBS Positive Control Pack
| Applicant | Diasorin Molecular, LLC, Cypress CA, US |
| Decision | Substantially Equivalent, Nov 7, 2018 |
| Received | Sep 10, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K182467
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.