FDA 510(k) Applications for Medical Device Product Code: NPQ (Test, Factor V Leiden Mutations, Genomic Dna Pcr)

FDA 510(k) Applications for Medical Device Product Code "NPQ"
(Test, Factor V Leiden Mutations, Genomic Dna Pcr)

FDA 510(k) Number	Applicant	Device Name	Decision Date
K060564	AUTOGENOMICS, INC	INFINITI SYSTEM	02/07/2007
K082118	CEPHEID	XPERT HEMOSIL FACTOR II & FACTOR V ASSAY	09/18/2009
K100980	HOLOGIC, INC.	INVADER FACTOR V	06/01/2011
K093129	ILLUMINA, INC.	ILLUMINA VERNCODE GENOTYPING TEST FOR FACOR V AND FACTOR II	04/28/2010
K093974	OSMETECH MOLECULAR DIAGNOSTICS	ESENOR FII-FV-MTHFR GENOTYPING TEST, ESENOR FII-FV GENOTYPING TEST, ESENOR FII GENOTYPING	04/22/2010
DEN030005	ROCHE DIAGNOSTICS CORP.	FACTOR V LEIDEN KIT	12/17/2003