510(k) K172868 ยท DCN System, Test, C-Reactive Protein
Optilite C-Reactive Protein Reagent,Optilite C-Reactive Protein Calibrator,Optilite C-Reactive Protein Controls
| Applicant | The Binding Site Group , Ltd., Birmingham, GB |
| Decision | Substantially Equivalent, Feb 28, 2018 |
| Received | Sep 20, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K172868
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 12, 2019 | The Binding Site Group, Ltd. Optilite C-Reactive Protein Kit - Product Usage: The Optilite C-Reactive Protein Reagent is intended for the quantitative in vitro determination of C-reactive protein (CRP) concentration in serum usin Terminated |
DCN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.