K-number	DEN160033
Device name	ARK Voriconazole II Assay Test System
Applicant	Ark Diagnostics, Inc.
Product code	PUJ
Device class	Class II
Decision date	May 5, 2017
Decision	Not Substantially Equivalent
Regulation	—

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View the full FDA submission: accessdata.fda.gov

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ARK Voriconazole II Assay Test System

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