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EMIT D.A.U. Urine Cannabinoid Calibra

by Syva Co. 510(k)

Active United States

510(k) K834457

Overview

This device is a calibrator for drug-specific testing, as indicated by its device name and classification. It is intended for use in clinical toxicology settings to calibrate assays that detect cannabinoids in human urine.

The device was cleared via the FDA 510(k) process under K834457, with a traditional clearance pathway and a decision date of June 22, 1984. It is manufactured by Syva Co. and classified under product code DLJ and regulation number 862.3200.

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 NumberK834457 Date22 Jun 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
DLJ
Device Class
Class II
Regulation
21 CFR Part 862.3200
Advisory Committee
Clinical Toxicology
FDA Decision
SESE Substantially Equivalent

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Questions

  • What is the EMIT D.A.U. Urine Cannabinoid Calibrator used for?

    It is used to calibrate assays that detect cannabinoids in human urine within clinical toxicology settings, ensuring accurate measurement in drug-specific testing procedures.

  • Who manufactures the EMIT D.A.U. Urine Cannabinoid Calibrator and what is its FDA clearance number?

    The device is manufactured by Syva Co. and received FDA 510(k) clearance under submission number K834457, granted on June 22, 1984, through a traditional clearance pathway.

  • What regulatory classification and product code apply to the EMIT D.A.U. Urine Cannabinoid Calibrator?

    It is classified as a Class II medical device under product code DLJ and regulation number 862.3200, with an advisory committee classification in Clinical Toxicology.