Celltracks Analyzer II System

• • Terminated Z-1195-2014 FDA Class II ·initiated 8 Jan 2014

  Janssen Diagnostics, LLC received complaints of camera failures on the CELLTRACKS ANALYZER II.

510(k) Number

K130794 ↗

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

• 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

See all devices from Veridex, LLC →