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EMIT 700 Opiate Assay

by Syva Co. 510(k)

Active United States

510(k) K843162

Overview

The EMIT 700 Opiate Assay is an enzyme immunoassay for opiates, classified as a Class II medical device under regulation number 862.3650. It is designed for the detection of opiates in clinical specimens using immunoassay technology.

The device received traditional 510(k) clearance (K843162) from the FDA on September 14, 1984, and is substantially equivalent to a legally marketed predicate device. It is manufactured by Syva Co. and is intended for use in clinical toxicology settings.

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

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK843162 Date14 Sep 1984ClearedStatusActive

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
DJG
Device Class
Class II
Regulation
21 CFR Part 862.3650
Advisory Committee
Clinical Toxicology
FDA Decision
SESE Substantially Equivalent

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Questions

  • What is the EMIT 700 Opiate Assay used for?

    The EMIT 700 Opiate Assay is designed for the detection of opiates in clinical specimens using immunoassay technology, intended for use in clinical toxicology settings to screen for opiate presence as part of diagnostic testing.

  • How is the EMIT 700 Opiate Assay supplied and what is its regulatory classification?

    The EMIT 700 Opiate Assay is supplied as an enzyme immunoassay reagent system for in vitro diagnostic use, classified as a Class II medical device under regulation 862.3650, and received traditional 510(k) clearance (K843162) from the FDA based on substantial equivalence to a predicate device.

  • Who manufactures the EMIT 700 Opiate Assay and where is it made?

    The EMIT 700 Opiate Assay is manufactured by Syva Co., with manufacturing operations located at 803 N. Front St. Suite 3, McHenry, IL 60050, United States, as indicated in the device registration and listing information.