510(k) K152389 ยท PDE Immunoglobulin M Kappa Heavy And Light Chain Combined
Optilite Hevylite IgM Kappa Kit; Optilite Hevylite IgM Lambda Kit
| Applicant | The Binding Site Group , Ltd., Birmingham, GB |
| Decision | Substantially Equivalent, Dec 18, 2015 |
| Received | Aug 24, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K152389
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.