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EMIT HVA Amphetamine Assay

by Syva Co. 510(k)

Active United States

510(k) K882589

Overview

This is an enzyme immunoassay for amphetamine detection, classified under Clinical Toxicology. It is a diagnostic device intended for the qualitative and/or quantitative detection of amphetamines in specimens.

The device received FDA 510(k) clearance (K882589) on August 2, 1988, as a substantially equivalent traditional submission. It is manufactured by Syva Co. and assigned product code DKZ under regulation number 862.3100.

AI-generated from registry data, 6 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 NumberK882589 Date2 Aug 1988ClearedStatusActive

Coverage

1 jurisdiction

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  • 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  • Withdrawn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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