510(k) Report

FDA applicant

Danam Electronics

Dallas, TX4 decisions1984–19950 recalls

FDA records 4 decisions for Danam Electronics (Dallas, TX) from 1984 to 1995: 4 510(k) clearances. Most are in product codes GKZ (Counter, Differential Cell) and GKL (Counter, Cell, Automated (Particle Counter)). 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, hematology panel, where it files most

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

FDA decisions per year

No FDA decision for Danam Electronics since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Which product codes does it file in?

  • GKZCounter, Differential Cell3decisions
  • GKLCounter, Cell, Automated (Particle Counter)1decision

Who builds on its devices?

Later devices cite its devices 2 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.

  • K945678Datacell 18MSDanam Electronics · 19952cite it

What has FDA decided for it lately?

  • K945678Datacell 18MSDanam Electronics · 1995
  • K910283Danam Datacell-18Danam Electronics · 1991
  • K892205Danam Vector-8+Danam Electronics · 1989
  • K840649Danam Elec. SA-1000Danam Electronics · 1984

All 4 as Danam Electronics →