Drugs of Abuse Calibrator

No FDA recalls found in the data synced 6 Oct 2026.

510(k) Number

K950139 ↗

FDA Product Code

DKB

Device Class

Class II

Regulation

21 CFR Part 862.3200

Advisory Committee

Clinical Toxicology

FDA Decision

SESE Substantially Equivalent

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See all devices from E.I. Dupont DE Nemours & Co., Inc. →

• What is the Drugs of Abuse Calibrator used for?

  The Drugs of Abuse Calibrator is a Class 2 device specifically designed for calibrating drug testing equipment in clinical toxicology settings. It helps ensure accurate and reliable results in drug testing procedures by providing standardized drug mixtures for equipment calibration.

• How is the Drugs of Abuse Calibrator supplied?

  The device is supplied by E.I. Dupont DE Nemours & Co., Inc. It is regulated under product code DKB and is intended for use in clinical toxicology laboratories. No specific information regarding packaging quantities or supply formats is provided in the device data.

• Is the Drugs of Abuse Calibrator single-use or reusable?

  The device data does not specify whether the Drugs of Abuse Calibrator is designed for single-use or multiple uses. This information would need to be obtained directly from the manufacturer or product documentation to determine the appropriate usage protocol.

• What is the regulatory status of the Drugs of Abuse Calibrator?

  The Drugs of Abuse Calibrator is cleared through the Traditional 510(k) pathway with FDA clearance number K950139. It is classified as a Class 2 device and is regulated under product code DKB for use in clinical toxicology laboratories.