K-number	K180209
Device name	Diazyme 1,5-AG Assay
Applicant	Diazyme Laboratories, Inc.
Product code	NOZ
Device class	Class II
Decision date	Oct 4, 2018
Decision	Substantially Equivalent
Regulation	864.7470

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View the full FDA submission: accessdata.fda.gov

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Diazyme 1,5-AG Assay

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