Diazyme Laboratories, Inc. - FDA 510(k) Cleared Devices
9
Total
9
Cleared
0
Denied
Diazyme Laboratories, Inc. has 9 FDA 510(k) cleared medical devices. Based in Poway, US.
Latest FDA clearance: Dec 2025. Active since 2018. Primary specialty: Chemistry.
Browse the FDA 510(k) cleared devices submitted by Diazyme Laboratories, Inc. Filter by specialty or product code using the sidebar.
FDA 510(k) cleared devices by Diazyme Laboratories, Inc.
9 devices
Cleared
Dec 19, 2025
Diazyme Human Kappa (k) Free Light Chain Assay
Immunology
80d
Cleared
Aug 01, 2025
Diazyme Colorimetric Lithium Assay
Chemistry
266d
Cleared
Sep 08, 2022
Diazyme Human Kappa Free Light Chain Assay, Diazyme Human Lambda Free Light...
Immunology
468d
Cleared
Aug 04, 2022
Diazyme Human Kappa Free Light Chain Assay, Diazyme Human Lambda Free Light...
Immunology
212d
Cleared
Dec 13, 2021
Diazyme DZ-Lite iFlash Total beta-hCG Assay, Diazyme DZ-Lite iFlash 1800...
Chemistry
150d
Cleared
Aug 06, 2021
Diazyme PLAC® Test for Lp-PLA2 Activity
Chemistry
290d
Cleared
Oct 04, 2018
Diazyme 1,5-AG Assay
Chemistry
253d
Cleared
Jun 26, 2018
Diazyme Human Kappa Free Light Chain Assay
Immunology
25d
Cleared
Mar 22, 2018
Diazyme Lipoprotein (a) Assay
Chemistry
71d