K-number	K182384
Device name	ACR LAB Urine Analysis Test System
Applicant	Healthy.Io, Ltd.
Product code	JFY
Device class	Class II
Decision date	Jul 26, 2019
Decision	Substantially Equivalent
Regulation	862.1225

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Source

View the full FDA submission: accessdata.fda.gov

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ACR LAB Urine Analysis Test System

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