510(k) Report

FDA applicant

Pandex Laboratories, Inc.

Mundelein, IL2 decisions1985–19860 recalls

FDA records 2 decisions for Pandex Laboratories, Inc. (Mundelein, IL) from 1985 to 1986: 2 510(k) clearances. All are in product code JZT (Fluorometer). 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, immunology panel, where it files most

How often FDA has decided Pandex Laboratories, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Pandex Laboratories, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Pandex Laboratories, 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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