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Veridex, LLC

FDA Regulatory Profile

Summary

Total Recalls
4
510(k) Clearances
12
Inspections
1
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-2406-2015Class IICell Search Circulating Tumor Kit. Intended for the enumeration of circulating tumor cells (CTC) of May 15, 2015
Z-1195-2014Class IICELLTRACKS ANALYZER II¿ (Product Code 9555) Product Usage: The CELLTRACKS ANALYZER II¿ is a seJanuary 8, 2014
Z-1949-2013Class IICELLTRACKS AUTOPREP System (Software Version 2.4.1 & Below. Product Usage: The CELLTRACKS AUTODecember 28, 2012
Z-1950-2013Class IICELLTRACKS ANALYZER II (Software Version 2.5.1 & Below. Product Usage: The CELLTRACKS AUTOPREPDecember 28, 2012

Recent 510(k) Clearances

K-NumberDeviceDate
K130794CELLTRACKS ANALYZER II SYSTEMJune 20, 2013
K122821CELLTRACKS AUTOPREP SYSTEMDecember 13, 2012
K110406CELLTRACKS AUTOPREP SYSTEMJanuary 20, 2012
K113181CELLTRACKS ANALYER IIDecember 12, 2011
K103502CELLSEARCH CIRCULATING TUMOR CELL KIT MODEL 7900001December 21, 2010
K100684CELLTRACKS AUTOPREP SYSTEM MODEL:9541August 26, 2010
K073338CELLSEARCH CIRCULATING TUMOR CELL KITFebruary 26, 2008
K071729CELLSEARCH CIRCULATING TUMOR CELL KITNovember 20, 2007
K062013CELLSEARCH CIRCULATING TUMOR CELL KITDecember 14, 2006
K052191MODIFICATION TO CELLSEARCH CIRCULATING TUMOR CELL KITOctober 27, 2005
K050245CELLSEARCH CIRCULATING TUMOR CELL KITMarch 15, 2005
K040898CELLSEARCH EPITHELIAL CELL CONTROL KITJune 28, 2004