Diagnostics makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 2 spellings of its name, each linked to the record.
As of Nov 14, 2026, FDA's public records list Diazyme Laboratories with 52 510(k) clearances. The most recent is a 510(k) clearance dated Jun 16, 2026: Lipoprotein (a) Molarity Assay.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Jun 16, 2026 | Lipoprotein (a) Molarity AssayK253069 · DFC | 510(k) clearances |
| Apr 24, 2026 | Diazyme Immunoglobulin A Assay; Diazyme Immunoglobulin G Assay; Diazyme Immunoglobulin M AssayK252336 · | 510(k) clearances |
| Dec 19, 2025 | Diazyme Human Kappa (k) Free Light Chain Assay; Diazyme Human Lambda (¿) Free Light Chain AssayK253358 · DFH | 510(k) clearances |
| Aug 1, 2025 | Diazyme Colorimetric Lithium AssayK243462 · NDW | 510(k) clearances |
| Sep 8, 2022 | Diazyme Human Kappa Free Light Chain Assay, Diazyme Human Lambda Free Light Chain AssayK211648 · DFH | 510(k) clearances |
| Aug 4, 2022 | Diazyme Human Kappa Free Light Chain Assay, Diazyme Human Lambda Free Light Chain AssayK220001 · DFH | 510(k) clearances |
| Dec 13, 2021 | Diazyme DZ-Lite iFlash Total beta-hCG Assay, Diazyme DZ-Lite iFlash 1800 Chemiluminescence Immunoassay AnalyzerK212221 · DHA | 510(k) clearances |
| Aug 6, 2021 | Diazyme PLAC® Test for Lp-PLA2 ActivityK203136 · NOE | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
