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510(k) K100684

CELLTRACKS AUTOPREP SYSTEM MODEL:9541 by Veridex, LLC — Product Code GKH

K100684 is an FDA 510(k) premarket notification submitted by Veridex, LLC for the device "CELLTRACKS AUTOPREP SYSTEM MODEL:9541". The FDA issued a decision of Substantially Equivalent on August 26, 2010. The device falls under product code GKH (Apparatus, Automated Blood Cell Diluting), a Class I device regulated under 21 CFR 864.5240. Veridex, LLC has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 26, 2010
Date Received
March 10, 2010
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Apparatus, Automated Blood Cell Diluting
Device Class
Class I
Regulation Number
864.5240
Review Panel
HE
Submission Type

Other clearances by Veridex, LLC

  • K130794 — CELLTRACKS ANALYZER II SYSTEM (June 20, 2013)
  • K122821 — CELLTRACKS AUTOPREP SYSTEM (December 13, 2012)
  • K110406 — CELLTRACKS AUTOPREP SYSTEM (January 20, 2012)
  • K113181 — CELLTRACKS ANALYER II (December 12, 2011)
  • K103502 — CELLSEARCH CIRCULATING TUMOR CELL KIT MODEL 7900001 (December 21, 2010)
  • K073338 — CELLSEARCH CIRCULATING TUMOR CELL KIT (February 26, 2008)
  • K071729 — CELLSEARCH CIRCULATING TUMOR CELL KIT (November 20, 2007)
  • K062013 — CELLSEARCH CIRCULATING TUMOR CELL KIT (December 14, 2006)
  • K052191 — MODIFICATION TO CELLSEARCH CIRCULATING TUMOR CELL KIT (October 27, 2005)
  • K050245 — CELLSEARCH CIRCULATING TUMOR CELL KIT (March 15, 2005)

Other clearances for product code GKH

  • K040077 — IMMUNICON CELLTRACKS AUTOPREP SYSTEM (March 12, 2004)
  • K022512 — CELLPREP SAMPLE PREPARATION SYSTEM, MODEL 9518 (September 30, 2002)
  • K021150 — COULTER CELLPREP (June 11, 2002)
  • K935953 — COULTER MULTI Q PREP (March 11, 1994)
  • K923530 — COULTER MULTI-Q-PREP (October 14, 1992)
  • K904795 — FACSPREP ROBOTIC SAMPLE PREPARATION SYSTEM (December 31, 1990)
  • K882767 — SYSMEX DD-100 WHOLE BLOOD DILUTION SYSTEM (July 18, 1988)
  • K852373 — AD150, AUTOMATED HEMATOLOGY DILUTOR (July 5, 1985)
  • K842747 — HYCEL DILUTOR, VARIOUS MODELS/MULTI (October 1, 1984)
  • K842446 — DILU-MATIC 140 (September 6, 1984)

FDA data resources