FDA applicant

Coulter Immunology

Hialeah, FL16 decisions1988–19930 recalls

FDA records 16 decisions for Coulter Immunology (Hialeah, FL) from 1988 to 1993: 16 510(k) clearances. Most are in product codes GKZ (Counter, Differential Cell) and DEW (Igg, Antigen, Antiserum, Control). 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 Coulter Immunology’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Coulter Immunology since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Coulter Immunology 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 Electronics, Inc. 101 Coulter Corp. 51

Coulter Immunology

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?

Other applicant names beginning “Coulter”