Diazyme Immunoglobulin A Assay; Diazyme Immunoglobulin G Assay; Diazyme Immunoglobulin M Assay
| Applicant | Diazyme Laboratories, Inc., Poway CA, US |
| Decision | Substantially Equivalent, Apr 24, 2026 |
| Received | Jul 28, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K252336
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.