SYNCHRON SYSTEMS OPIATES 2000 NG (OP2) REAGENT— 510(k) K984152

Name: FDA 510(k) clearance K984152
Creator: U.S. Food and Drug Administration
Published: 1999-01-29

Substantially Equivalent

Beckman Coulter, Inc.

FDA 510(k) clearance K984152 for SYNCHRON SYSTEMS OPIATES 2000 NG (OP2) REAGENT, Substantially Equivalent on 1999-01-29. Applicant: Beckman Coulter, Inc.. Device class: 2.

Clearance details

Applicant: Beckman Coulter, Inc.
Product code: Code DJG
Device class: Class 2
Regulation: 21 CFR 862.3650
Advisory panel: Clinical Toxicology
Date received: 1998-11-19
Decision date: 1999-01-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Brea, CA, US

Download summary PDF View on FDA.gov ↗

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Recalls naming K984152

K-number listed on FDA's recall record

Z-1751-2020 — Synchron Systems Opiate 2000 ng Reagent (OP2 1 x 250); catalogue no. 475006 for use in conjunction with UniCel DxC 600/800 System(s) and SYNCHRON Systems Drugs of Abuse Testing (DAT) Urine Calibrators. The assay provides a rapid screening procedure for presence of the analyte in urine.Class II·Terminated·Beckman Coulter Inc.·20190904

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K984152.

Data sourced from openFDA. This site is unofficial and independent of the FDA.