Diazyme Laboratories, Inc.
FDA 510(k) & PMA Approved Devices — 10 products
Total Devices10
Categories6
Latest Approval2026-04-24
| Type | Number | Device Name | Code | Date | |
|---|---|---|---|---|---|
| 510(k) | K252336 | Diazyme Immunoglobulin A Assay; Diazyme Immunoglobulin G Assay; Diazyme Immunoglobulin M Assay | 2026-04-24 | View | |
| 510(k) | K253358 | Diazyme Human Kappa (k) Free Light Chain Assay; Diazyme Human Lambda (¿) Free Light Chain Assay | DFH | 2025-12-19 | View |
| 510(k) | K243462 | Diazyme Colorimetric Lithium Assay | NDW | 2025-08-01 | View |
| 510(k) | K211648 | Diazyme Human Kappa Free Light Chain Assay, Diazyme Human Lambda Free Light Chain Assay | DFH | 2022-09-08 | View |
| 510(k) | K220001 | Diazyme Human Kappa Free Light Chain Assay, Diazyme Human Lambda Free Light Chain Assay | DFH | 2022-08-04 | View |
| 510(k) | K212221 | Diazyme DZ-Lite iFlash Total beta-hCG Assay, Diazyme DZ-Lite iFlash 1800 Chemiluminescence Immunoassay Analyzer | DHA | 2021-12-13 | View |
| 510(k) | K203136 | Diazyme PLAC® Test for Lp-PLA2 Activity | NOE | 2021-08-06 | View |
| 510(k) | K180209 | Diazyme 1,5-AG Assay | NOZ | 2018-10-04 | View |
| 510(k) | K181438 | Diazyme Human Kappa Free Light Chain Assay; Diazyme Human Lambda Free Light Chain Assay | DFH | 2018-06-26 | View |
| 510(k) | K180074 | Diazyme Lipoprotein (a) Assay | DFC | 2018-03-22 | View |
No matching devices.