FDA applicant

Abbott Rapid Diagnostics

San Diego, CA1 decision2017–20172 recalls

FDA records 1 decision for Abbott Rapid Diagnostics (San Diego, CA) in 2017: 1 510(k) clearance. All are in product code LCP (Assay, Glycosylated Hemoglobin). Its devices cite 4 predicates, 0 of them its own earlier devices. 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 Abbott Rapid Diagnostics’s devices, and how often a recall has named them.

FDA decisions per year

1in 2017

2017high 1 (2017) · low 0 (2018)2026

2026 so far, outlined.

Recalls per year

1in 2025

2017high 1 (2024) · low 0 (2017)2026

Class I Class II/III not classified

FIG. 1 — Abbott Rapid Diagnostics by year, 2017–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Abbott Rapid Diagnostics’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 Rapid 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?

What has been recalled?

Other applicant names beginning “Abbott”