Diazyme Laboratories, Inc. - FDA 510(k) Cleared Devices
10
Total
10
Cleared
0
Denied
5 devices
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