510(k) K132555 ยท PCN Immunoglobulin G Kappa Heavy And Light Chain Combined
HEVYLITE HUMAN IGG KAPPA KIT AND HEVYLITE HUMAN IGG LAMBDA KIT
| Applicant | The Binding Site, Birmingham, GB |
| Decision | Substantially Equivalent, Dec 20, 2013 |
| Received | Aug 14, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K132555
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.