FDA 510(k) Applications Submitted by Chao Dou

FDA 510(k) Number Submission Date Device Name Applicant
K212221 07/16/2021 Diazyme DZ-Lite iFlash Total beta-hCG Assay, Diazyme DZ-Lite iFlash 1800 Chemiluminescence Immunoassay Analyzer Diazyme Laboratories Inc.
K203136 10/20/2020 Diazyme PLAC« Test for Lp-PLA2 Activity Diazyme Laboratories Inc.


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