Celltracks Autoprep System MODEL:9541

No FDA recalls found in the data synced 11 Oct 2026.

510(k) Number

K100684 ↗

FDA Product Code

GKH

Device Class

Class I

Regulation

21 CFR Part 864.5240

Advisory Committee

Hematology

FDA Decision

SESE Substantially Equivalent

• 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

• Celltracks Analyer II

  Class II

  FDA 510(k) K113181 Active Cleared 12 Dec 2011

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