510(k) Report

FDA applicant

Cozart Bioscience, Ltd.

Oxfordshire Ox14 4ru, GB6 decisions2001–20040 recalls

FDA records 6 decisions for Cozart Bioscience, Ltd. (Oxfordshire Ox14 4ru, GB) from 2001 to 2004: 6 510(k) clearances. Most are in product codes DKZ (Enzyme Immunoassay, Amphetamine) and MKU (Enzyme Immunoassay, Nicotine And Nicotine…). Its devices cite 3 predicates, 0 of them its own earlier 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, clinical toxicology panel, where it files most

How often FDA has decided Cozart Bioscience, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Cozart Bioscience, Ltd. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Cozart Bioscience, Ltd.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • DKZEnzyme Immunoassay, Amphetamine1decision
  • MKUEnzyme Immunoassay, Nicotine And Nicotine Metabolites1decision
  • DJGEnzyme Immunoassay, Opiates1decision
  • DIGCholinesterase Test Paper1decision
  • DIOEnzyme Immunoassay, Cocaine And Cocaine Metabolites1decision
  • DJREnzyme Immunoassay, Methadone1decision

Whose devices does it build on?

Its devices cite 3 predicates; 0 are its own earlier devices. The firms it cites most:

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.

  • K033743Cozart Eia Amphetamines Oral Fluid Microplate KitCozart Bioscience, Ltd. · 20041cites it

What has FDA decided for it lately?

  • K033743Cozart Eia Amphetamines Oral Fluid Microplate KitCozart Bioscience, Ltd. · 2004
  • K021944Cozart Eia Cotinine Urine KitCozart Bioscience, Ltd. · 2003
  • K030234Cozart Eia Cocaine Oral Fliud KitCozart Bioscience, Ltd. · 2003
  • K024339Cozart Eia Opiates Oral Fluid KitCozart Bioscience, Ltd. · 2003
  • K020920Cozart Rapiscan Oral Fluid Drug Test - Opiate/MethadoneCozart Bioscience, Ltd. · 2002
  • K011131Methadone Microplate Eia Urine ApplicationCozart Bioscience, Ltd. · 2001

All 6 as Cozart Bioscience, Ltd. →