K-number	K033548
Device name	ROCHE DIAGNOSTICS URISYS 1100 URINE ANALYZER
Applicant	Roche Diagnostics Corp.
Product code	KHE
Device class	Class II
Decision date	Nov 24, 2003
Decision	Substantially Equivalent
Regulation	864.6550

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View the full FDA submission: accessdata.fda.gov

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ROCHE DIAGNOSTICS URISYS 1100 URINE ANALYZER

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