K-number	K163274
Device name	AggreGuide A-100 AA Assay, AggreGuide A-100 Instrument
Applicant	Aggredyne, Inc.
Product code	JOZ
Device class	Class II
Decision date	Apr 5, 2017
Decision	Substantially Equivalent
Regulation	864.5700

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Source

View the full FDA submission: accessdata.fda.gov

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AggreGuide A-100 AA Assay, AggreGuide A-100 Instrument

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