510(k) K103502

CELLSEARCH CIRCULATING TUMOR CELL KIT MODEL 7900001 by Veridex, LLC — Product Code NQI

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: December 21, 2010
Date Received: November 29, 2010
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)
K113181 — CELLTRACKS ANALYER II (December 12, 2011)
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)
K113181 — CELLTRACKS ANALYER II (December 12, 2011)
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)