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Psychemedics Methamphetamine EIA

by Psychemedics Corp. 510(k)

Active United States

510(k) K111927

Overview

The Psychemedics Methamphetamine EIA is an enzyme immunoassay device used for the qualitative detection of methamphetamine in human hair samples. This device is designed to provide laboratory professionals with a reliable method for detecting methamphetamine use through hair analysis.

The device is supplied as a kit containing all necessary components for testing and is intended for single-use in laboratory settings. It is not MRI compatible and should be stored according to the manufacturer's instructions. The device has received FDA 510(k) clearance with the product code LAF and is classified as Class II under regulation number 862.3610.

AI-generated from registry data, 23 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK111927 Date1 May 2012ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
LAF
Device Class
Class II
Regulation
21 CFR Part 862.3610
Advisory Committee
Clinical Toxicology
FDA Decision
SESE Substantially Equivalent

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Questions

  • What is the Psychemedics Methamphetamine EIA used for?

    The Psychemedics Methamphetamine EIA is an enzyme immunoassay device designed for the qualitative detection of methamphetamine in human hair samples. It provides laboratory professionals with a reliable method for detecting methamphetamine use through hair analysis.

  • How is the Psychemedics Methamphetamine EIA supplied?

    The device is supplied as a complete kit containing all necessary components for testing. It is intended for single-use in laboratory settings and should be stored according to the manufacturer's instructions. It is not MRI compatible.

  • What is the regulatory status of the Psychemedics Methamphetamine EIA?

    The device has received FDA 510(k) clearance with the product code LAF and is classified as Class II under regulation number 862.3610. It was determined to be substantially equivalent through the traditional clearance process.

  • Is the Psychemedics Methamphetamine EIA reusable or single-use?

    The Psychemedics Methamphetamine EIA is designed for single-use only. After testing, the device should be disposed of properly according to laboratory protocols and manufacturer instructions. It is not intended for reuse or multiple testing.