Diazyme Laboratories, Inc. FDA Approvals

0 new drug approvals and 8 device clearances on file. This applicant is not matched to a listed company.

Newest first

A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.

Product	What it is	Route	Decided
Lipoprotein (a) Molarity Assay510(k)Jun 16, 2026Immunology	Immunology	510(k)Substantially Equivalent (Traditional)	Jun 16, 2026
Diazyme Immunoglobulin A Assay; Diazyme Immunoglobulin G Assay; Diazyme Immunoglobulin M Assay510(k)Apr 24, 2026	—	510(k)Substantially Equivalent (Traditional)	Apr 24, 2026
Diazyme Human Kappa (k) Free Light Chain Assay; Diazyme Human Lambda (¿) Free Light Chain Assay510(k)Dec 19, 2025Immunology	Immunology	510(k)Substantially Equivalent (Traditional)	Dec 19, 2025
Diazyme Colorimetric Lithium Assay510(k)Aug 1, 2025Clinical Toxicology	Clinical Toxicology	510(k)Substantially Equivalent (Traditional)	Aug 1, 2025
Diazyme Human Kappa Free Light Chain Assay, Diazyme Human Lambda Free Light Chain Assay510(k)Sep 8, 2022Immunology	Immunology	510(k)Substantially Equivalent (Traditional)	Sep 8, 2022
Diazyme Human Kappa Free Light Chain Assay, Diazyme Human Lambda Free Light Chain Assay510(k)Aug 4, 2022Immunology	Immunology	510(k)Substantially Equivalent (Traditional)	Aug 4, 2022
Diazyme DZ-Lite iFlash Total beta-hCG Assay, Diazyme DZ-Lite iFlash 1800 Chemiluminescence Immunoassay Analyzer510(k)Dec 13, 2021Clinical Chemistry	Clinical Chemistry	510(k)Substantially Equivalent (Traditional)	Dec 13, 2021
Diazyme PLAC® Test for Lp-PLA2 Activity510(k)Aug 6, 2021Immunology	Immunology	510(k)Substantially Equivalent (Special)	Aug 6, 2021