510(k) K161854 ยท PCN Immunoglobulin G Kappa Heavy And Light Chain Combined
Hevylite Human IgG Kappa Kit for use on the SPAPLUS, Hevylite Human IgG Lambda Kit for use on the SPAPLUS
| Applicant | The Binding Site Group , Ltd., Edgbaston, GB |
| Decision | Substantially Equivalent, Oct 4, 2016 |
| Received | Jul 6, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K161854
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.