Cellsearch Epithelial Cell Control Kit

• • Terminated Z-1472-2011 FDA Unclassified (pre-2012) ·initiated 9 Nov 2010

  There is a discrepancy between the assigned range of values on the high control label and the range listed on the Cell control Assigned Value Label for the Cell Search Circulating Tumor Cell Control Kit.

510(k) Number

K040898 ↗

FDA Product Code

NRS

Device Class

Class II

Regulation

21 CFR Part 864.8625

Advisory Committee

Hematology

FDA Decision

SESE Substantially Equivalent

• Celltracks Autoprep System MODEL:9541

  Class I

  FDA 510(k) K100684 Active Cleared 26 Aug 2010

• Cellsearch Circulating Tumor Cell Kit

  Class II

  FDA 510(k) K062013 Active Cleared 14 Dec 2006

• Celltracks Autoprep System

  Class II

  FDA 510(k) K110406 Active Cleared 20 Jan 2012

• Celltracks Analyzer II System

  Class II

  FDA 510(k) K130794 Active Cleared 20 Jun 2013

• Cellsearch Circulating Tumor Cell Kit Model 7900001 Open recall

  Class II

  FDA 510(k) K103502 Active Cleared 21 Dec 2010

• Celltracks Analyer II

  Class II

  FDA 510(k) K113181 Active Cleared 12 Dec 2011

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