510(k) K151759 ยท OPX Immunoglobulin A Kappa Heavy & Light Chain Combined
Hevylite Human IgA Kappa Kit for use on SPAPLUS, Hevylite Human IgA Lambda Kit for use on SPAPLUS
| Applicant | The Binding Site Group , Ltd., Edgbaston, GB |
| Decision | Substantially Equivalent, Nov 6, 2015 |
| Received | Jun 29, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K151759
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.