Home / 510(k) Clearances / K040898

510(k) K040898

CELLSEARCH EPITHELIAL CELL CONTROL KIT by Veridex, LLC — Product Code NRS

K040898 is an FDA 510(k) premarket notification submitted by Veridex, LLC for the device "CELLSEARCH EPITHELIAL CELL CONTROL KIT". The FDA issued a decision of Substantially Equivalent on June 28, 2004. The device falls under product code NRS (Control Material, Blood Circulating Epithelial Cancer Cell), a Class II device regulated under 21 CFR 864.8625. Veridex, LLC has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 28, 2004
Date Received
April 6, 2004
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Control Material, Blood Circulating Epithelial Cancer Cell
Device Class
Class II
Regulation Number
864.8625
Review Panel
HE
Submission Type

The Epithelial Cell Control Kit contains two levels of fixed cells that are stained with a fluorescence marker and are used to verify sample processing and cell analysis of circulating tumor cells. This device is used as an assay quality control to ensure that sample detection and identification systems are able to detect circulating epithelial tumor cells.

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)
  • K100684 — CELLTRACKS AUTOPREP SYSTEM MODEL:9541 (August 26, 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)

FDA data resources