Evidence MultiSTAT DOA Urine MultiPlex— 510(k) K221550

Name: FDA 510(k) clearance K221550
Creator: U.S. Food and Drug Administration
Published: 2023-10-05

Substantially Equivalent

Randox Laboratories Limited

FDA 510(k) clearance K221550 for Evidence MultiSTAT DOA Urine MultiPlex, 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: 2022-05-31
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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