CELLSEARCH CIRCULATING TUMOR CELL KIT— 510(k) K071729

Name: FDA 510(k) clearance K071729
Creator: U.S. Food and Drug Administration
Published: 2007-11-20

Substantially Equivalent

Veridex, LLC

FDA 510(k) clearance K071729 for CELLSEARCH CIRCULATING TUMOR CELL KIT, Substantially Equivalent on 2007-11-20. 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: 2007-06-25
Decision date: 2007-11-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Raritan, NJ, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code NQI

view all

K130794 — CELLTRACKS ANALYZER II SYSTEM2013-06-20
K122821 — CELLTRACKS AUTOPREP SYSTEM2012-12-13
K110406 — CELLTRACKS AUTOPREP SYSTEM2012-01-20
K113181 — CELLTRACKS ANALYER II2011-12-12
K103502 — CELLSEARCH CIRCULATING TUMOR CELL KIT MODEL 79000012010-12-21

More clearances from Veridex, LLC

view all

K100684 — CELLTRACKS AUTOPREP SYSTEM MODEL:95412010-08-26
K073338 — CELLSEARCH CIRCULATING TUMOR CELL KIT2008-02-26
K062013 — CELLSEARCH CIRCULATING TUMOR CELL KIT2006-12-14
K052191 — MODIFICATION TO CELLSEARCH CIRCULATING TUMOR CELL KIT2005-10-27
K050245 — CELLSEARCH CIRCULATING TUMOR CELL KIT2005-03-15

Data sourced from openFDA. This site is unofficial and independent of the FDA.