510(k) K163418 ยท DHA System, Test, Human Chorionic Gonadotropin
Diazyme DZ-Lite Total beta-hCG Test System
| Applicant | Diazyme Laboratories, Poway CA, US |
| Decision | Substantially Equivalent, Aug 18, 2017 |
| Received | Dec 6, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K163418
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.