K-number	K171883
Device name	Sysmex UF-5000 Fully Automated Urine Particle Analyzer
Applicant	Sysmex America, Inc.
Product code	LKM
Device class	Class II
Decision date	Apr 23, 2018
Decision	Substantially Equivalent
Regulation	864.5200

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Source

View the full FDA submission: accessdata.fda.gov

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Sysmex UF-5000 Fully Automated Urine Particle Analyzer

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