510(k) K160819 ยท OPX Immunoglobulin A Kappa Heavy & Light Chain Combined
Optilite Hevylite IgA Kappa Kit, Optilite Hevylite IgA Lambda Kit
| Applicant | The Binding Site Group , Ltd., Edgbaston, GB |
| Decision | Substantially Equivalent, Jun 16, 2016 |
| Received | Mar 24, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K160819
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.