510(k) K161982 ยท DCN System, Test, C-Reactive Protein
C-Reactive Protein Kit for use on SPAPLUS
| Applicant | The Binding Site Group, Birmingham, GB |
| Decision | Substantially Equivalent, Apr 5, 2017 |
| Received | Jul 19, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K161982
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 31, 2020 | The Binding Site Group, Ltd. C-Reactive Protein Kit for use on the SPAplus, REF NK044.S.A, Rx only, UDI (01)05051700018456, Terminated |
DCN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.