K-number	K203136
Device name	Diazyme PLAC® Test for Lp-PLA2 Activity
Applicant	Diazyme Laboratories, Inc.
Product code	NOE
Device class	Class II
Decision date	Aug 6, 2021
Decision	Substantially Equivalent
Regulation	866.5600

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View the full FDA submission: accessdata.fda.gov

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Diazyme PLAC® Test for Lp-PLA2 Activity

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