510(k) K203227 ยท DHA System, Test, Human Chorionic Gonadotropin
Elecsys HCG STAT
| Applicant | Roche Diagnostics, Indianapolis IN, US |
| Decision | Substantially Equivalent, Aug 18, 2021 |
| Received | Nov 2, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K203227
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.