510(k) K182513 ยท OZE Influenza A And Influenza B Multiplex Nucleic Acid Assay
FluChip-8G Influenza A+B Assay
| Applicant | Indevr, Inc., Boulder CO, US |
| Decision | Substantially Equivalent, Apr 22, 2019 |
| Received | Sep 12, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K182513
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.