510(k) Report

FDA applicant

United Diagnostics, Inc.

Mchenry, IL12 decisions1979–19890 recalls

FDA records 12 decisions for United Diagnostics, Inc. (Mchenry, IL) from 1979 to 1989: 12 510(k) clearances. Most are in product codes JJY (Multi-Analyte Controls, All Kinds (Assayed)) and JJS (Controls For Blood-Gases, (Assayed And…). 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 United Diagnostics, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for United Diagnostics, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like United Diagnostics, Inc.’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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