K-number	K232416
Device name	AUTION EYE AI-4510 Urine Particle Analysis System
Applicant	Arkray, Inc.
Product code	LKM
Device class	Class II
Decision date	May 3, 2024
Decision	Substantially Equivalent
Regulation	864.5200

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Source

View the full FDA submission: accessdata.fda.gov

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AUTION EYE AI-4510 Urine Particle Analysis System

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