510(k) K040898

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

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.

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