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Synchron Systems Opiates 2000 Ng (OP2) Reagent

by Beckman Coulter, Inc.

510(k) K984152

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK984152 Date29 Jan 1999ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-1751-2020 FDA Class II initiated 4 Sep 2019

    Cross-reactivity testing may not meet the claims indicated in the Opiate 2000 ng (OP2) Instructions For Use. The presence of certain compounds in urine may result in false positive or false negative patient test results.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

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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