510(k) Report

FDA applicant

Chemlink Laboratories, LLC

Washington, DC1 decision1999–19990 recalls

FDA records 1 decision for Chemlink Laboratories, LLC (Washington, DC) in 1999: 1 510(k) clearance. All are in product code LRJ (Disinfectant, Medical Devices). 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, general hospital panel, where it files most

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

FDA decisions per year

No FDA decision for Chemlink Laboratories, LLC since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Which product codes does it file in?

  • LRJDisinfectant, Medical Devices1decision

What has FDA decided for it lately?

  • K984485Microstat 2Chemlink Laboratories, LLC · 1999

The one decision as Chemlink Laboratories, LLC →