K-number	K040174
Device name	BILIRUBIN ASSAY ON THE OMNI S ANALYZER
Applicant	Roche Diagnostics Corp.
Product code	MQM
Device class	Class I
Decision date	May 14, 2004
Decision	Substantially Equivalent
Regulation	862.1113

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View the full FDA submission: accessdata.fda.gov

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BILIRUBIN ASSAY ON THE OMNI S ANALYZER

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