FDA 510(k) Applications for Medical Device Product Code: NQI (System, Immunomagnetic, Circulating Cancer Cell, Enumeration)

FDA 510(k) Applications for Medical Device Product Code "NQI"
(System, Immunomagnetic, Circulating Cancer Cell, Enumeration)

FDA 510(k) Number	Applicant	Device Name	Decision Date
DEN040001	ADVANCED DIAGNOSTIC SYSTEMS	CELLSEARCH EPITHELIAL CELL ENRICHMENT KIT; CELLSPOTTER SYSTEM	01/21/2004
K050145	IMMUNICON CORP.	CELLTRACKA ANALYZER II	03/15/2005
K060110	IMMUNICON CORP.	CELLTRACKS ANALYZER II	03/16/2006
K050245	VERIDEX, LLC	CELLSEARCH CIRCULATING TUMOR CELL KIT	03/15/2005
K071729	VERIDEX, LLC	CELLSEARCH CIRCULATING TUMOR CELL KIT	11/20/2007
K073338	VERIDEX, LLC	CELLSEARCH CIRCULATING TUMOR CELL KIT	02/26/2008
K062013	VERIDEX, LLC	CELLSEARCH CIRCULATING TUMOR CELL KIT	12/14/2006
K103502	VERIDEX, LLC	CELLSEARCH CIRCULATING TUMOR CELL KIT MODEL 7900001	12/21/2010
K113181	VERIDEX, LLC	CELLTRACKS ANALYER II	12/12/2011
K130794	VERIDEX, LLC	CELLTRACKS ANALYZER II SYSTEM	06/20/2013
K110406	VERIDEX, LLC	CELLTRACKS AUTOPREP SYSTEM	01/20/2012
K122821	VERIDEX, LLC	CELLTRACKS AUTOPREP SYSTEM	12/13/2012
K052191	VERIDEX, LLC	MODIFICATION TO CELLSEARCH CIRCULATING TUMOR CELL KIT	10/27/2005