CELLTRACKS ANALYZER II SYSTEM— 510(k) K130794

Substantially Equivalent

Veridex, LLC

FDA 510(k) clearance K130794 for CELLTRACKS ANALYZER II SYSTEM, Substantially Equivalent on 2013-06-20. 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: 2013-03-22
Decision date: 2013-06-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Raritan, NJ, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code NQI

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
K073338 — CELLSEARCH CIRCULATING TUMOR CELL KIT2008-02-26

More clearances from Veridex, LLC

K100684 — CELLTRACKS AUTOPREP SYSTEM MODEL:95412010-08-26
K071729 — CELLSEARCH CIRCULATING TUMOR CELL KIT2007-11-20
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

Recalls naming K130794

K-number listed on FDA's recall record

Z-1195-2014 — CELLTRACKS ANALYZER II¿ (Product Code 9555) Product Usage: The CELLTRACKS ANALYZER II¿ is a semi-automated fluorescence microscope, consisting of the analyzer, a dedicated computer with CELLTRACKS¿ software, monitor, keyboard, mouse and uninterruptible power supply (UPS). The system also supports an optional Remote Review Workstation (RRW), which consists of a dedicated computer with CELLTRACKS¿ software, monitor, keyboard and mouse. Use of this product requires training and should be used under the supervision of laboratory management. The CELLTRACKS ANALYZER II¿ is for analysis of rare cells that are isolated from biological fluids including whole blood. It is used in conjunction with the CELLTRACKS¿ AUTOPREP¿ System, which automates and standardizes the sample preparation with specific reagent kits. An optional Remote Review Workstation is also available to provide the capability to review images and report results remotely.Class II·Terminated·Veridex, LLC·20140108

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K130794.

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