Poway, CA, US · 8 510(k) clearances
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| DFH | Kappa, Antigen, Antiserum, Control | Class II | Immunology | 3 | 2025-12-19 |
| DFC | Lipoprotein, Low-Density, Antigen, Antiserum, Control | Class II | Immunology | 1 | 2026-06-16 |
| — | — | — | — | 1 | 2026-04-24 |
| NDW | Assay, Porphyrin, Spectrophotometry, Lithium | Class II | Clinical Toxicology | 1 | 2025-08-01 |
| DHA | System, Test, Human Chorionic Gonadotropin | Class II | Clinical Chemistry | 1 | 2021-12-13 |
| NOE | Test, System, Immunoassay, Lipoprotein-Associated Phospholipase A2 | Class II | Immunology | 1 | 2021-08-06 |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2026-06-16 | K253069 | Lipoprotein (a) Molarity Assay | DFC | Class II | Immunology |
| 2026-04-24 | K252336 | Diazyme Immunoglobulin A Assay; Diazyme Immunoglobulin G Assay; Diazyme Immunoglobulin M Assay | — | — | — |
| 2025-12-19 | K253358 | Diazyme Human Kappa (k) Free Light Chain Assay; Diazyme Human Lambda (¿) Free Light Chain Assay | DFH | Class II | Immunology |
| 2025-08-01 | K243462 | Diazyme Colorimetric Lithium Assay | NDW | Class II | Clinical Toxicology |
| 2022-09-08 | K211648 | Diazyme Human Kappa Free Light Chain Assay, Diazyme Human Lambda Free Light Chain Assay | DFH | Class II | Immunology |
| 2022-08-04 | K220001 | Diazyme Human Kappa Free Light Chain Assay, Diazyme Human Lambda Free Light Chain Assay | DFH | Class II | Immunology |
| 2021-12-13 | K212221 | Diazyme DZ-Lite iFlash Total beta-hCG Assay, Diazyme DZ-Lite iFlash 1800 Chemiluminescence Immunoassay Analyzer | DHA | Class II | Clinical Chemistry |
| 2021-08-06 | K203136 | Diazyme PLAC® Test for Lp-PLA2 Activity | NOE | Class II | Immunology |