CELLSEARCH CIRCULATING TUMOR CELL KIT— 510(k) K062013

Name: FDA 510(k) clearance K062013
Creator: U.S. Food and Drug Administration
Published: 2006-12-14

Substantially Equivalent

Veridex, LLC

FDA 510(k) clearance K062013 for CELLSEARCH CIRCULATING TUMOR CELL KIT, Substantially Equivalent on 2006-12-14. Applicant: Veridex, LLC. Device class: 2.

Clearance details

Applicant: Veridex, LLC
Product code: Code NQI
Device class: Class 2
Regulation: 21 CFR 866.6020
Advisory panel: Immunology
Date received: 2006-07-17
Decision date: 2006-12-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Warren, NJ, US

Download summary PDF View on FDA.gov ↗

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K113181 — CELLTRACKS ANALYER II2011-12-12
K103502 — CELLSEARCH CIRCULATING TUMOR CELL KIT MODEL 79000012010-12-21

More clearances from Veridex, LLC

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K100684 — CELLTRACKS AUTOPREP SYSTEM MODEL:95412010-08-26
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K071729 — CELLSEARCH CIRCULATING TUMOR CELL KIT2007-11-20
K052191 — MODIFICATION TO CELLSEARCH CIRCULATING TUMOR CELL KIT2005-10-27
K050245 — CELLSEARCH CIRCULATING TUMOR CELL KIT2005-03-15

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