Cleared Traditional

Evidence MultiSTAT DOA Urine MultiPlex

K221550 · Randox Laboratories Limited · Toxicology
Oct 2023
Decision
492d
Days
Class 2
Risk

About This 510(k) Submission

K221550 is an FDA 510(k) clearance for the Evidence MultiSTAT DOA Urine MultiPlex, a Enzyme Immunoassay, Opiates (Class II — Special Controls, product code DJG), submitted by Randox Laboratories Limited (Crumlin, GB). The FDA issued a Cleared decision on October 5, 2023, 492 days after receiving the submission on May 31, 2022. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3650.

Submission Details

510(k) Number K221550 FDA.gov
FDA Decision Cleared SESE
Date Received May 31, 2022
Decision Date October 05, 2023
Days to Decision 492 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF

Device Classification

Product Code DJG — Enzyme Immunoassay, Opiates
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3650

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