K-number	K063520
Device name	ROCHE TOTAL MYCOPHENOLIC ACID ASSAY, CALIBRATORS AND CONTROLS
Applicant	Roche Diagnostics
Product code	OAV
Device class	Class II
Decision date	Feb 16, 2007
Decision	Substantially Equivalent
Regulation	862.3840

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ROCHE TOTAL MYCOPHENOLIC ACID ASSAY, CALIBRATORS AND CONTROLS

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