510(k) K203136 · NOE Test, System, Immunoassay, Lipoprotein-Associated Phospholipase A2
Diazyme PLAC® Test for Lp-PLA2 Activity
| Applicant | Diazyme Laboratories, Inc., Poway CA, US |
| Decision | Substantially Equivalent, Aug 6, 2021 |
| Received | Oct 20, 2020 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K203136
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.