FDA 510(k) Application Details - K203136

Device Classification Name	Test, System, Immunoassay, Lipoprotein-Associated Phospholipase A2   More FDA Info for this Device
510(K) Number	K203136
Device Name	Test, System, Immunoassay, Lipoprotein-Associated Phospholipase A2
Applicant	Diazyme Laboratories Inc. 12889 Gregg Court Poway, CA 92064 US Other 510(k) Applications for this Company
Contact	Chao Dou Other 510(k) Applications for this Contact
Regulation Number	866.5600   More FDA Info for this Regulation Number
Classification Product Code	NOE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/20/2020
Decision Date	08/06/2021
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	IM - Immunology
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Statement
Type	Special
Reviewed By Third Party	N
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