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