510(k) Report

FDA applicant

Advanced Diagnostic Systems

Raritan, NJ1 decision2004–20040 recalls

FDA records 1 decision for Advanced Diagnostic Systems (Raritan, NJ) in 2004: 1 De Novo grant. All are in product code NQI (System, Immunomagnetic, Circulating Cancer…). No recall is linked to its devices.

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

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

How often FDA has decided Advanced Diagnostic Systems’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Advanced Diagnostic Systems since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Advanced Diagnostic Systems’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, Enumeration1decision

Who builds on its devices?

Later devices cite its devices 3 times; 0 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.

  • DEN040001Cellsearch Epithelial Cell Enrichment Kit; Cellspotter SystemAdvanced Diagnostic Systems · 20043cite it

What has FDA decided for it lately?

  • DEN040001Cellsearch Epithelial Cell Enrichment Kit; Cellspotter SystemAdvanced Diagnostic Systems · 2004

The one decision as Advanced Diagnostic Systems →