510(k) DEN160003 ยท OYX Bcr/Abl1 Monitoring Test
Quantidex qPCR BCR-ABL IS Kit
| Applicant | Asuragen, Inc., Austin TX, US |
| Decision | Unknown, Jul 22, 2016 |
| Received | Jan 19, 2016 |
| Type | Direct |
| FDA record | Open on fda.gov |
Recalls that name DEN160003
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.