US device clearances
19 510(k) clearances and PMA approvals since 2015
- Lipoprotein (A) Molarity Assay K253069 · 16 Jun 2026
- Diazyme Immunoglobulin A Assay; Diazyme Immunoglobulin G Assay; Diazyme Immunog… K252336 · 24 Apr 2026
- Diazyme Human Kappa (K) Free Light Chain Assay; Diazyme Human Lambda (¿) Free L… K253358 · 19 Dec 2025
- Diazyme Colorimetric Lithium Assay K243462 · 1 Aug 2025
- Diazyme Human Kappa Free Light Chain Assay, Diazyme Human Lambda Free Light Cha… K211648 · 8 Sep 2022
Source: FDA 510(k) and PMA databases, 510(k) clearances, and PMA approvals or changes, since 2015; newest shown. Retrieved 13 Nov 2026.
