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510(k) K050145

CELLTRACKA ANALYZER II by Immunicon Corp. — Product Code NQI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 15, 2005
Date Received
January 24, 2005
Clearance Type
Traditional
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 Immunicon Corp.

  • K060110 — CELLTRACKS ANALYZER II (March 16, 2006)
  • K040077 — IMMUNICON CELLTRACKS AUTOPREP SYSTEM (March 12, 2004)
  • K030263 — IMMUNICON CELLTRACKS ANALYZER (November 24, 2003)
  • K030596 — IMMUNICON CELLSAVE PRESERVATIVE TUBE (August 8, 2003)
  • K022512 — CELLPREP SAMPLE PREPARATION SYSTEM, MODEL 9518 (September 30, 2002)

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)
  • 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)