510(k) K140686 ยท PDE Immunoglobulin M Kappa Heavy And Light Chain Combined
HEVYLITE HUMAN IGM KAPPA AND LAMBDA KIT FOR USE ON SPAPLUS
| Applicant | The Binding Site Group , Ltd., Birmingham, GB |
| Decision | Substantially Equivalent, Aug 6, 2014 |
| Received | Mar 19, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K140686
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.