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Wondfo Amphetamine Urine Test, Wondfo Barbiturates Urine Test, Wondfo Benzodiaz…

FDA 510(k)

Class II (US FDA 510(k))

510(k) K111560

by Guangzhou Wondfo Biotech Co., Ltd.

Identifiers

510(k) Number
K111560 FDA 510(k)
FDA Product Code
DKZ FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 862.3100 FDA 510(k)
Regulation Number
862.3100 FDA 510(k)
Advisory Committee
Clinical Toxicology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Wondfo Amphetamine Urine Test, Wondfo Barbiturates Urine Test, and Wondfo Benzodiazepines Urine Test are enzyme immunoassay devices intended to measure amphetamine, barbiturates, and benzodiazepines in urine. These devices are used in the diagnosis and treatment of drug use or overdose and in monitoring levels to ensure appropriate therapy.

These tests are supplied as single-use devices and are intended for qualitative determination at specific cut-off concentrations in human urine. The device is classified as Class II and has FDA 510(k) clearance with the K number K111560. The manufacturer is Guangzhou Wondfo Biotech Co., Ltd.

Frequently asked questions

What is the purpose of the Wondfo Amphetamine, Barbiturates, and Benzodiazepines Urine Tests?

These enzyme immunoassay devices are intended to measure amphetamine, barbiturates, and benzodiazepines in urine. They are used in the diagnosis and treatment of drug use or overdose and in monitoring levels to ensure appropriate therapy.

Are these tests single-use or reusable?

These tests are supplied as single-use devices and are intended for qualitative determination at specific cut-off concentrations in human urine. They should not be reused for patient testing.

What is the regulatory status of these tests?

The device is classified as Class II and has FDA 510(k) clearance with the K number K111560. This means it has been determined to be substantially equivalent to other legally marketed devices.

How are these tests supplied?

The tests are supplied as single-use devices for qualitative determination at specific cut-off concentrations in human urine. They are intended for professional use in clinical settings for diagnostic purposes.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Wondfo Amphetamine Urine Test Wondfo Barbiturates Urine Test Wondfo ..., Wondfo Amphetamine Urine Test, Wondfo Barbiturates Urine Test, Wondfo ..., PDF K111560 - Wondfo Amphetamine Urine Test, Wondfo Barbiturates Urine Test ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Guangzhou Wondfo Biotech Co., Ltd.

Sources (1)

  • FDA 510(k) K111560 24 fields · synced Sep 24, 2026