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510(k) K113181

CELLTRACKS ANALYER II by Veridex, LLC — Product Code NQI

K113181 is an FDA 510(k) premarket notification submitted by Veridex, LLC for the device "CELLTRACKS ANALYER II". The FDA issued a decision of Substantially Equivalent on December 12, 2011. The device falls under product code NQI (System, Immunomagnetic, Circulating Cancer Cell, Enumeration), a Class II device regulated under 21 CFR 866.6020. Veridex, LLC has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 12, 2011
Date Received
October 28, 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)
  • K110406 — CELLTRACKS AUTOPREP SYSTEM (January 20, 2012)
  • 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)
  • K110406 — CELLTRACKS AUTOPREP SYSTEM (January 20, 2012)
  • 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)
  • K050145 — CELLTRACKA ANALYZER II (March 15, 2005)

FDA data resources