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EMIT-STM Amphetamine Assay

by Syva Co. 510(k)

Active United States

510(k) K802623

Overview

The EMIT-STM Amphetamine Assay is an enzyme immunoassay device used for the detection of amphetamines. It is intended for use in clinical toxicology to identify the presence of amphetamines in a sample.

The assay is supplied as a single-use, non-sterile device. It is not indicated for use in an MRI environment. The device is regulated as a Class II medical device and has received FDA 510(k) clearance.

AI-generated from registry data, 1 Oct 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK802623 Date12 Nov 1980ClearedStatusActive

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
DKZ
Device Class
Class II
Regulation
21 CFR Part 862.3100
Advisory Committee
Clinical Toxicology
FDA Decision
SESE Substantially Equivalent

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Questions

  • What is the EMIT-STM Amphetamine Assay used for?

    The EMIT-STM Amphetamine Assay is an enzyme immunoassay device used in clinical toxicology to identify the presence of amphetamines in a sample. It is designed for laboratory testing purposes.

  • Is the EMIT-STM Amphetamine Assay a single-use device?

    Yes, the EMIT-STM Amphetamine Assay is supplied as a single-use device. It is not sterile and is not intended for use in an MRI environment.

  • What is the regulatory classification of the EMIT-STM Amphetamine Assay?

    The EMIT-STM Amphetamine Assay is regulated as a Class II medical device and has received FDA 510(k) clearance. It is substantially equivalent to other devices in its class.

  • How is the EMIT-STM Amphetamine Assay supplied?

    The assay is supplied as a single-use, non-sterile device. It is not indicated for use in an MRI environment. The device is manufactured by Syva Co.