FDA applicant

Abbott Ireland Diagnostics Division

Longford, IE8 decisions2021–20230 recalls

FDA records 8 decisions for Abbott Ireland Diagnostics Division (Longford, IE) from 2021 to 2023: 8 510(k) clearances. Most are in product codes CIG (Diazo Colorimetry, Bilirubin) and CHH (Enzymatic Esterase--Oxidase, Cholesterol). Its devices cite 8 predicates, 0 of them its own earlier devices. 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, clinical chemistry panel, where it files most

How often FDA has decided Abbott Ireland Diagnostics Division’s devices, and how often a recall has named them.

FDA decisions per year

1in 2023

2021high 6 (2022) · low 0 (2024)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2021.

FIG. 1 — Abbott Ireland Diagnostics Division by year, 2021–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Abbott Ireland Diagnostics Division’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

Other applicant names beginning “Abbott”

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

Abbott Laboratories 920 Abbott Medical 92 Abbott Vascular 64 Abbott Diabetes Care, Inc. 42 Abbott Molecular, Inc. 33 Abbott Diagnostics 28 Abbott Point of Care, Inc. 22 Abbott Medical Optics, Inc. 16 Abbott Mfg., Inc. 14 Abbott 14 Abbott Spine, Inc. 13 Abbott Diagnostics Scarborough, Inc. 8

Abbott Ireland Diagnostics Division

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?

Other applicant names beginning “Abbott”