K-number	K172471
Device name	VENTANA CD30 (Ber-H2) RxDx Assay
Applicant	Ventana Medical Systems, Inc.
Product code	DEH
Device class	Class II
Decision date	May 8, 2018
Decision	Substantially Equivalent
Regulation	866.5550

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Source

View the full FDA submission: accessdata.fda.gov

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VENTANA CD30 (Ber-H2) RxDx Assay

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