510(k) K181438 ยท DFH Kappa, Antigen, Antiserum, Control
Diazyme Human Kappa Free Light Chain Assay; Diazyme Human Lambda Free Light Chain Assay
| Applicant | Diazyme Laboratories, Inc., Poway CA, US |
| Decision | Substantially Equivalent, Jun 26, 2018 |
| Received | Jun 1, 2018 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K181438
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.