510(k) Report

FDA applicant

ARUP Laboratories

Salt Lake City1 decision2023–20230 recalls

FDA records 1 decision for ARUP Laboratories (Salt Lake City) in 2023: 1 original PMA approval. All are in product code QWQ (Assays To Detect Pre-Existing Antibodies To…). 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 ARUP Laboratories’s devices, and how often a recall has named them.

FDA decisions per year

1in 2023

2023: 1
2023high 1 (2023) · low 0 (2024)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2023.

FIG. 1 — ARUP Laboratories by year, 2023–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like ARUP Laboratories’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