FDA 510(k) Application Details - K060564

Device Classification Name	Test, Factor V Leiden Mutations, Genomic Dna Pcr   More FDA Info for this Device
510(K) Number	K060564
Device Name	Test, Factor V Leiden Mutations, Genomic Dna Pcr
Applicant	AUTOGENOMICS, INC 2251 RUTHERFORD ROAD CARLSBAD, CA 92008 US Other 510(k) Applications for this Company
Contact	EVELYN LOPEZ Other 510(k) Applications for this Contact
Regulation Number	864.7280   More FDA Info for this Regulation Number
Classification Product Code	NPQ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/03/2006
Decision Date	02/07/2007
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HE - Hematology
Review Advisory Committee	PA - Pathology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review