CELLTRACKA ANALYZER II— 510(k) K050145

Substantially Equivalent

Immunicon Corp.

FDA 510(k) clearance K050145 for CELLTRACKA ANALYZER II, Substantially Equivalent on 2005-03-15. Applicant: Immunicon Corp.. Device class: 2.

Clearance details

Applicant: Immunicon Corp.
Product code: Code NQI
Device class: Class 2
Regulation: 21 CFR 866.6020
Advisory panel: Immunology
Date received: 2005-01-24
Decision date: 2005-03-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Huntingdon Valley, PA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code NQI

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 Immunicon Corp.

K060110 — CELLTRACKS ANALYZER II2006-03-16
K040077 — IMMUNICON CELLTRACKS AUTOPREP SYSTEM2004-03-12
K030263 — IMMUNICON CELLTRACKS ANALYZER2003-11-24
K030596 — IMMUNICON CELLSAVE PRESERVATIVE TUBE2003-08-08
K022512 — CELLPREP SAMPLE PREPARATION SYSTEM, MODEL 95182002-09-30

Recalls naming K050145

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 K050145.

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