Medical Device Manufacturer · US , Raritan , NJ

Veridex, LLC

12 submissions · 12 cleared · Since 2004
12
Total
12
Cleared
0
Denied

Veridex, LLC — FDA 510(k) Submissions

Veridex, LLC has submitted 12 FDA 510(k) premarket notifications since 2004, of which 12 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include System, Immunomagnetic, Circulating Cancer Cell, Enumeration, Control Material, Blood Circulating Epithelial Cancer Cell, Apparatus, Automated Blood Cell Diluting . Use the specialty filter in the sidebar to narrow results.

12 devices
1–12 of 12
CELLTRACKS ANALYZER II SYSTEM
K130794 · NQI System, Immunomagnetic,... · Pathology
Jun 2013 90d
CELLTRACKS AUTOPREP SYSTEM
K122821 · NQI System, Immunomagnetic,... · Pathology
Dec 2012 90d
CELLTRACKS AUTOPREP SYSTEM
K110406 · NQI System, Immunomagnetic,... · Pathology
Jan 2012 340d
CELLTRACKS ANALYER II
K113181 · NQI System, Immunomagnetic,... · Pathology
Dec 2011 45d
CELLSEARCH CIRCULATING TUMOR CELL KIT MODEL 7900001
K103502 · NQI System, Immunomagnetic,... · Pathology
Dec 2010 22d
CELLTRACKS AUTOPREP SYSTEM MODEL:9541
K100684 · GKH Apparatus, Automated... · Hematology
Aug 2010 169d
CELLSEARCH CIRCULATING TUMOR CELL KIT
K073338 · NQI System, Immunomagnetic,... · Pathology
Feb 2008 90d
CELLSEARCH CIRCULATING TUMOR CELL KIT
K071729 · NQI System, Immunomagnetic,... · Pathology
Nov 2007 148d
CELLSEARCH CIRCULATING TUMOR CELL KIT
K062013 · NQI System, Immunomagnetic,... · Pathology
Dec 2006 150d
MODIFICATION TO CELLSEARCH CIRCULATING TUMOR CELL KIT
K052191 · NQI System, Immunomagnetic,... · Pathology
Oct 2005 77d
CELLSEARCH CIRCULATING TUMOR CELL KIT
K050245 · NQI System, Immunomagnetic,... · Pathology
Mar 2005 41d
CELLSEARCH EPITHELIAL CELL CONTROL KIT
K040898 · NRS Control Material, Blood... · Hematology
Jun 2004 83d
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