510(k) K140105 ยท OPX Immunoglobulin A Kappa Heavy & Light Chain Combined
HEVYLITE HUMAN IGA KAPPA KIT FOR USE ON SIEMENS BNII, HEVYLITE HUMAN IGA LAMBDA KIT FOR USE ON SIEMENS BNII
| Applicant | The Binding Site, Birmingham, GB |
| Decision | Substantially Equivalent, Mar 18, 2014 |
| Received | Jan 15, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K140105
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.