K-number	DEN130018
Device name	CYTOSCAN(R) DX
Applicant	Affymetrix, Inc.
Product code	PFX
Device class	Class II
Decision date	Jan 17, 2014
Decision	Not Substantially Equivalent
Regulation	866.5920

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Source

View the full FDA submission: accessdata.fda.gov

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CYTOSCAN(R) DX

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