FDA 510(k) Applications for Medical Device Product Code "GKH"
(Apparatus, Automated Blood Cell Diluting)

FDA 510(k) Number Applicant Device Name Decision Date
K021150 BECKMAN COULTER, INC. COULTER CELLPREP 06/11/2002
K022512 IMMUNICON CORP. CELLPREP SAMPLE PREPARATION SYSTEM, MODEL 9518 09/30/2002
K040077 IMMUNICON CORP. IMMUNICON CELLTRACKS AUTOPREP SYSTEM 03/12/2004
K100684 VERIDEX, LLC CELLTRACKS AUTOPREP SYSTEM MODEL:9541 08/26/2010


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