Celltracks Analyer II

• • Terminated Z-1004-2012 FDA Unclassified (pre-2012) ·initiated 17 Aug 2011

  Control cell images may i intermix with Patient cell images while changing between the Control review screen and Patient review screen on the Cell tracks Analyzer II.

510(k) Number

K113181 ↗

FDA Product Code

NQI

Device Class

Class II

Regulation

21 CFR Part 866.6020

Advisory Committee

Immunology

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

• Cellsearch Epithelial Cell Control Kit

  Class II

  FDA 510(k) K040898 Active Cleared 28 Jun 2004

• 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

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