K-number	K071867
Device name	RAPID GENOTYPING ASSAY -CYP2C9 & VKORC1, MODEL CATALOG NO. 006+0203 GACTGA
Applicant	Paragondx, LLC
Product code	ODV
Device class	Class II
Decision date	Apr 28, 2008
Decision	Substantially Equivalent
Regulation	864.7750

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RAPID GENOTYPING ASSAY -CYP2C9 & VKORC1, MODEL CATALOG NO. 006+0203 GACTGA

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