510(k) K180074 ยท DFC Lipoprotein, Low-Density, Antigen, Antiserum, Control
Diazyme Lipoprotein (a) Assay
| Applicant | Diazyme Laboratories, Inc., Poway CA, US |
| Decision | Substantially Equivalent, Mar 22, 2018 |
| Received | Jan 10, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K180074
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.