Evidence MultiSTAT DOA Urine MultiPlex, Evidence MultiSTAT— 510(k) K220451

Name: FDA 510(k) clearance K220451
Creator: U.S. Food and Drug Administration
Published: 2023-10-05

Substantially Equivalent

Randox Laboratories Limited

FDA 510(k) clearance K220451 for Evidence MultiSTAT DOA Urine MultiPlex, Evidence MultiSTAT, Substantially Equivalent on 2023-10-05. Applicant: Randox Laboratories Limited. Device class: 2.

Clearance details

Applicant: Randox Laboratories Limited
Product code: Code DJG
Device class: Class 2
Regulation: 21 CFR 862.3650
Advisory panel: Clinical Toxicology
Date received: 2022-02-17
Decision date: 2023-10-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Crumlin, GB

Download summary PDF View on FDA.gov ↗

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Recalls naming K220451

K-number listed on FDA's recall record

Z-1786-2024 — Evidence MultiSTAT with software v 3.7-Analyzer intended for the qualitative determination of parent drug molecule and metabolites of drugs in human urine Catalog Number: EV4115Class III·Ongoing·Randox Laboratories Ltd.·20240405

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K220451.

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