Home / 510(k) Clearances / DEN040001

510(k) DEN040001

CELLSEARCH EPITHELIAL CELL ENRICHMENT KIT; CELLSPOTTER SYSTEM by Advanced Diagnostic Systems — Product Code NQI

Clearance Details

Decision
DENG (De Novo Granted)
Decision Date
January 21, 2004
Date Received
January 2, 2004
Clearance Type
Post-NSE
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 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)