FDA applicant

Coulter Electronics, Inc.

Hialeah, FL101 decisions1976–19942 recalls

FDA records 101 decisions for Coulter Electronics, Inc. (Hialeah, FL) from 1976 to 1994: 101 510(k) clearances. Most are in product codes GKL (Counter, Cell, Automated (Particle Counter)) and GKZ (Counter, Differential Cell). 2 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 Coulter Electronics, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Coulter Electronics, Inc. since 2007.

Recalls per year

1in 2011

2007high 1 (2010) · low 0 (2007)2026

Class I Class II/III not classified

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

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Other applicant names beginning “Coulter”

FDA records each applicant name separately; these may or may not be the same firm.

Coulter Corp. 51 Coulter Immunology 16

Coulter Electronics, Inc.

Which product codes does it file in?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

What has been recalled?

Other applicant names beginning “Coulter”