K-number	K053135
Device name	SYSMEX UF-100I AUTOMATED URINE CELL ANALYZER
Applicant	Sysmex America, Inc.
Product code	LKM
Device class	Class II
Decision date	Jan 4, 2006
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-100I AUTOMATED URINE CELL ANALYZER

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