K-number	K182062
Device name	Sysmex UD-10, Fully Automated Urine Particle Digital Imaging Device
Applicant	Sysmex America, Inc.
Product code	JOY
Device class	Class II
Decision date	Oct 30, 2018
Decision	Substantially Equivalent
Regulation	864.5260

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View the full FDA submission: accessdata.fda.gov

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Sysmex UD-10, Fully Automated Urine Particle Digital Imaging Device

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