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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Test, System, Immunoassay, Lipoprotein-Associated Phospholipase A2
510(k) Number K203136
Device Name Diazyme PLAC® Test for Lp-PLA2 Activity
Applicant
Diazyme Laboratories, Inc.
12889 Gregg Ct.
Poway,  CA  92064
Applicant Contact Chao Dou
Correspondent
Diazyme Laboratories, Inc.
12889 Gregg Ct.
Poway,  CA  92064
Correspondent Contact Chao Dou
Regulation Number866.5600
Classification Product Code
NOE  
Date Received10/20/2020
Decision Date 08/06/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Clinical Chemistry
Statement Statement
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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