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510(k) K110406

CELLTRACKS AUTOPREP SYSTEM by Veridex, LLC — Product Code NQI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 20, 2012
Date Received
February 14, 2011
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Immunomagnetic, Circulating Cancer Cell, Enumeration
Device Class
Class II
Regulation Number
866.6020
Review Panel
PA
Submission Type

In vitro diagnostic device to aid in the enumeration of immunomagnetically selected and fluorescently identified circulating tumor cells of epithelial origin in whole blood for prediction of cancer progression and survival.

Other clearances by Veridex, LLC

  • K130794 — CELLTRACKS ANALYZER II SYSTEM (June 20, 2013)
  • K122821 — CELLTRACKS AUTOPREP SYSTEM (December 13, 2012)
  • K113181 — CELLTRACKS ANALYER II (December 12, 2011)
  • K103502 — CELLSEARCH CIRCULATING TUMOR CELL KIT MODEL 7900001 (December 21, 2010)
  • K100684 — CELLTRACKS AUTOPREP SYSTEM MODEL:9541 (August 26, 2010)
  • K073338 — CELLSEARCH CIRCULATING TUMOR CELL KIT (February 26, 2008)
  • K071729 — CELLSEARCH CIRCULATING TUMOR CELL KIT (November 20, 2007)
  • K062013 — CELLSEARCH CIRCULATING TUMOR CELL KIT (December 14, 2006)
  • K052191 — MODIFICATION TO CELLSEARCH CIRCULATING TUMOR CELL KIT (October 27, 2005)
  • K050245 — CELLSEARCH CIRCULATING TUMOR CELL KIT (March 15, 2005)

Other clearances for product code NQI

  • K130794 — CELLTRACKS ANALYZER II SYSTEM (June 20, 2013)
  • K122821 — CELLTRACKS AUTOPREP SYSTEM (December 13, 2012)
  • K113181 — CELLTRACKS ANALYER II (December 12, 2011)
  • K103502 — CELLSEARCH CIRCULATING TUMOR CELL KIT MODEL 7900001 (December 21, 2010)
  • K073338 — CELLSEARCH CIRCULATING TUMOR CELL KIT (February 26, 2008)
  • K071729 — CELLSEARCH CIRCULATING TUMOR CELL KIT (November 20, 2007)
  • K062013 — CELLSEARCH CIRCULATING TUMOR CELL KIT (December 14, 2006)
  • K060110 — CELLTRACKS ANALYZER II (March 16, 2006)
  • K052191 — MODIFICATION TO CELLSEARCH CIRCULATING TUMOR CELL KIT (October 27, 2005)
  • K050245 — CELLSEARCH CIRCULATING TUMOR CELL KIT (March 15, 2005)