510(k) K253069 ยท DFC Lipoprotein, Low-Density, Antigen, Antiserum, Control
Lipoprotein (a) Molarity Assay
| Applicant | Diazyme Laboratories, Inc., Poway CA, US |
| Decision | Substantially Equivalent, Jun 16, 2026 |
| Received | Sep 23, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K253069
No recall in the FDA data names this 510(k).
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