FDA applicant

Abbott Diagnostics

Mountain View, CA28 decisions1981–199717 recalls

FDA records 28 decisions for Abbott Diagnostics (Mountain View, CA) from 1981 to 1997: 28 510(k) clearances. Most are in product codes GKL (Counter, Cell, Automated (Particle Counter)) and GKZ (Counter, Differential Cell). Its devices cite 3 predicates, 0 of them its own earlier devices. 17 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 Abbott Diagnostics’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Abbott Diagnostics since 2007.

Recalls per year

4in 2009

2007high 4 (2007) · low 0 (2008)2026

Class I Class II/III not classified

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

Planning a device like Abbott Diagnostics’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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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 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 8

Abbott Diagnostics

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

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Other applicant names beginning “Abbott”