510(k) K180099 ยท DCN System, Test, C-Reactive Protein
Optilite High Sensitivity C-Reactive Protein Kit
| Applicant | The Binding Site Group , Ltd., Birmingham, GB |
| Decision | Substantially Equivalent, Oct 12, 2018 |
| Received | Jan 16, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K180099
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.