FDA 510(k) Application Details - K071867

Device Classification Name	Vitamin K Epoxide Reductase Complex Subunit One (Vkorc1) Genotyping System   More FDA Info for this Device
510(K) Number	K071867
Device Name	Vitamin K Epoxide Reductase Complex Subunit One (Vkorc1) Genotyping System
Applicant	PARAGONDX, LLC 133 SOUTHCENTER COURT SUITE 200 MORRISVILLE, NC 27560 US Other 510(k) Applications for this Company
Contact	DEBORAH N KLOOS Other 510(k) Applications for this Contact
Regulation Number	864.7750   More FDA Info for this Regulation Number
Classification Product Code	ODV Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/06/2007
Decision Date	04/28/2008
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HE - Hematology
Review Advisory Committee	TX - Clinical Toxicology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review