510(k) Report

FDA applicant

Marion Laboratories, Inc.

Mchenry, IL38 decisions1978–19890 recalls

FDA records 38 decisions for Marion Laboratories, Inc. (Mchenry, IL) from 1978 to 1989: 38 510(k) clearances. Most are in product codes LLH (Reagents, Clostridium Difficile Toxin) and LJF (Device, Antimicrobial Drug Removal). 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, microbiology panel, where it files most

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

FDA decisions per year

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

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Marion 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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Other applicant names beginning “Marion”

FDA records each applicant name separately; these may or may not be the same firm.