510(k) K160070 ยท DHR System, Test, Rheumatoid Factor
Rheumatoid Factor (RF) Kit for use on SPAPLUS
| Applicant | The Binding Site Group , Ltd., Edgbaston, GB |
| Decision | Substantially Equivalent, Dec 7, 2016 |
| Received | Jan 13, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K160070
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 6, 2019 | The Binding Site Group, Ltd. Rheumatoid Factor (RF) Kit for use on SPAPLUS, for in-vitro diagnostic use, Product code: LK151.S.A. , UDI: 05051700018319 Terminated |
DHR | None listed |
| Jan 4, 2018 | The Binding Site Group, Ltd. Rheumatoid Factor (RF) Kit for use on SPAPLUS, Product #LK151.S.A
Intended for the quantitative in-vitro measurement of rheumatoid factor in serum using the Binding Site SPAPLUS analyser. Measurement Terminated |
DHR | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.