510(k) Report

FDA applicant

American Drug Screens, Inc.

Oklahoma City1 decision1994–19940 recalls

FDA records 1 decision for American Drug Screens, Inc. (Oklahoma City) in 1994: 1 original PMA approval. All are in product code MGX (Test System, For Drugs Of Abuse). 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 chemistry panel, where it files most

How often FDA has decided American Drug Screens, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for American Drug Screens, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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