Medical Device Manufacturer · US , Poway , CA

Diazyme Laboratories, Inc. - FDA 510(k) Cleared Devices

11 submissions · 11 cleared · Since 2018

Recent clearances: Diazyme Immunoglobulin A Assay, Diazyme Human Kappa (k) Free Light Chain Assay, Diazyme Colorimetric Lithium Assay

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11

Total

11

Cleared

0

Denied

FDA 510(k) Regulatory Record - Diazyme Laboratories, Inc. Chemistry ✕

6 devices

1-6 of 6

Cleared Jun 16, 2026

Lipoprotein (a) Molarity Assay

Chemistry · 266d

Cleared Aug 01, 2025

Diazyme Colorimetric Lithium Assay

Chemistry · 266d

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 Mar 22, 2018

Diazyme Lipoprotein (a) Assay

Chemistry · 71d