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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name vitamin k epoxide reductase complex subunit one (vkorc1) genotyping system
510(k) Number K071867
Device Name RAPID GENOTYPING ASSAY -CYP2C9 & VKORC1, MODEL CATALOG NO. 006+0203 GACTGA
Applicant
PARAGONDX, LLC
133 SOUTHCENTER COURT
SUITE 200
morrisville,  NC  27560
Applicant Contact deborah n kloos
Correspondent
PARAGONDX, LLC
133 SOUTHCENTER COURT
SUITE 200
morrisville,  NC  27560
Correspondent Contact deborah n kloos
Regulation Number864.7750
Classification Product Code
ODV  
Subsequent Product Code
ODW  
Date Received07/06/2007
Decision Date 04/28/2008
Decision substantially equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Toxicology
statement statement
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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