K-number	K153607
Device name	ROMA Calculation Tool Using Elecsys Assays
Applicant	Roche Diagnostics
Product code	ONX
Device class	Class II
Decision date	Jun 15, 2016
Decision	Substantially Equivalent
Regulation	866.6050

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Source

View the full FDA submission: accessdata.fda.gov

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ROMA Calculation Tool Using Elecsys Assays

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