FDA 510(k) Applications for Medical Device Product Code "ODV"
(Vitamin K Epoxide Reductase Complex Subunit One (Vkorc1) Genotyping System)

FDA 510(k) Number Applicant Device Name Decision Date
K071867 PARAGONDX, LLC RAPID GENOTYPING ASSAY -CYP2C9 & VKORC1, MODEL CATALOG NO. 006+0203 GACTGA 04/28/2008


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