510(k) K211648 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, Sep 8, 2022 |
| Received | May 28, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K211648
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.