K-number	K130189
Device name	XTAG CYP2D6 KIT V3 (INCLUDING TDAS CYP2D6 SOFTWARE)
Applicant	Luminex Molecular Diagnostics, Inc.
Product code	NTI
Device class	Class II
Decision date	May 21, 2013
Decision	Substantially Equivalent
Regulation	862.3360

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View the full FDA submission: accessdata.fda.gov

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XTAG CYP2D6 KIT V3 (INCLUDING TDAS CYP2D6 SOFTWARE)

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