510(k) Report

FDA applicant

Kaulson Laboratories, Inc.

Mchenry, IL4 decisions1983–19830 recalls

FDA records 4 decisions for Kaulson Laboratories, Inc. (Mchenry, IL) in 1983: 4 510(k) clearances. Most are in product codes DIF (Drug Mixture Control Materials) and JJX (Single (Specified) Analyte Controls (Assayed…). 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 toxicology panel, where it files most

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

FDA decisions per year

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

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Kaulson Laboratories, Inc. 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?

  • DIFDrug Mixture Control Materials3decisions
  • JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)1decision

Who builds on its devices?

Later devices cite its devices 1 time; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K830234Contox Heavymetals ControlKaulson Laboratories, Inc. · 19831cites it

What has FDA decided for it lately?

  • K830493Protoporphyrin ZN ControlKaulson Laboratories, Inc. · 1983
  • K830492Contox Durg ControlKaulson Laboratories, Inc. · 1983
  • K830494Contox Drug Screen ControlKaulson Laboratories, Inc. · 1983
  • K830234Contox Heavymetals ControlKaulson Laboratories, Inc. · 1983

All 4 as Kaulson Laboratories, Inc. →