K-number	K121516
Device name	VIRTUOSO SYSTEM FOR IHC HER2 (4B5)
Applicant	Ventana Medical Systems, Inc.
Product code	NQN
Device class	Class II
Decision date	Sep 26, 2013
Decision	Substantially Equivalent
Regulation	864.1860

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View the full FDA submission: accessdata.fda.gov

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VIRTUOSO SYSTEM FOR IHC HER2 (4B5)

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