510(k) Report

FDA applicant

Immunicon Corp.

Huntingdon Valley, PA6 decisions2002–20064 recalls

FDA records 6 decisions for Immunicon Corp. (Huntingdon Valley, PA) from 2002 to 2006: 6 510(k) clearances. Most are in product codes NQI (System, Immunomagnetic, Circulating Cancer…) and GKH (Apparatus, Automated Blood Cell Diluting). Its devices cite 2 predicates, 1 of them its own earlier devices. 4 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, hematology panel, where it files most

How often FDA has decided Immunicon Corp.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Immunicon Corp. since 2007.

Recalls per year

1in 2014

2009: 12010: 12011: 12014: 1
2007high 1 (2009) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Immunicon Corp. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Immunicon Corp.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • NQISystem, Immunomagnetic, Circulating Cancer Cell, Enumeration2decisions
  • GKHApparatus, Automated Blood Cell Diluting2decisions
  • JKATubes, Vials, Systems, Serum Separators, Blood Collection1decision
  • GKZCounter, Differential Cell1decision

Whose devices does it build on?

Its devices cite 2 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 4 times; 1 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K050145Celltracka Analyzer IIImmunicon Corp. · 20051cites it
  • K040077Immunicon Celltracks Autoprep SystemImmunicon Corp. · 20041cites it
  • K030596Immunicon Cellsave Preservative TubeImmunicon Corp. · 20031cites it
  • K060110Celltracks Analyzer IIImmunicon Corp. · 20061cites it

What has FDA decided for it lately?

  • K060110Celltracks Analyzer IIImmunicon Corp. · 20061 recall
  • K050145Celltracka Analyzer IIImmunicon Corp. · 20052 recalls
  • K040077Immunicon Celltracks Autoprep SystemImmunicon Corp. · 20042 recalls
  • K030263Immunicon Celltracks AnalyzerImmunicon Corp. · 2003
  • K030596Immunicon Cellsave Preservative TubeImmunicon Corp. · 2003
  • K022512Cellprep Sample Preparation System, Model 9518Immunicon Corp. · 2002

All 6 as Immunicon Corp. →

What has been recalled?

4 recalls linked to its devices; the latest:

  • K050145CELLTRACKS ANALYZER II¿ (Product Code 9555) Product Usage: The CELLTRACKS ANALYZER II¿…Jan 8, 2014Class II
  • K050145CellTracks Analyzer II. A semi-automated fluorescence microscope used to enumerate…Aug 17, 2011
  • K040077CellTracks Auto Prep System, Circulating Tumor Cell Kit (epithelial, IVD Veridex, LLC a…May 19, 2010
  • K040077CellTracks AutoPrep System for in vitro diagnostic use, software version 2.2 or greater.…May 6, 2009