510(k) K172613 ยท PCN Immunoglobulin G Kappa Heavy And Light Chain Combined
Optilite Hevylite IgG Kappa Kit, Optilite Hevylite IgG Lambda Kit
| Applicant | The Binding Site Group , Ltd., Birmingham, GB |
| Decision | Substantially Equivalent, Feb 15, 2018 |
| Received | Aug 31, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K172613
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.