510(k) K162263 ยท DHR System, Test, Rheumatoid Factor
Optilite Rheumatoid Factor Kit
| Applicant | The Binding Site Group , Ltd., Birmingham, GB |
| Decision | Substantially Equivalent, May 3, 2017 |
| Received | Aug 11, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K162263
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 7, 2019 | The Binding Site Group, Ltd. Optilite Optilite Rheumatoid Factor Kit, Ref: LK151.OPT.A, IVD, Rx Only, UDI: 05051700020015 (kit ea. containing four components) Terminated |
DHR | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.