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. Immunology ✕

5 devices

1-5 of 5

Cleared Apr 24, 2026

Diazyme Immunoglobulin A Assay

Immunology · 270d

Cleared Dec 19, 2025

Diazyme Human Kappa (k) Free Light Chain Assay

Immunology · 80d

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 Jun 26, 2018

Diazyme Human Kappa Free Light Chain Assay

Immunology · 25d