510(k) K153394 ยท DFH Kappa, Antigen, Antiserum, Control
Diazyme Human Kappa Free Light Chain Assay, Diazyme Human Lambda Free Light Chain Assay, Diazyme Human Kappa/Lamda Free Light Chain Calibrator, Diazyme Human Kappa/Lamda Free Light Chain Calibrator
| Applicant | Diazyme Laboratories, Poway CA, US |
| Decision | Substantially Equivalent, Nov 18, 2016 |
| Received | Nov 24, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K153394
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.