Cleared Traditional

Evidence MultiSTAT DOA Urine MultiPlex, Evidence MultiSTAT

K220451 · Randox Laboratories Limited · Chemistry
Oct 2023
Decision
595d
Days
Class 2
Risk

About This 510(k) Submission

K220451 is an FDA 510(k) clearance for the Evidence MultiSTAT DOA Urine MultiPlex, Evidence MultiSTAT, 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, 595 days after receiving the submission on February 17, 2022. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.3650.

Submission Details

510(k) Number K220451 FDA.gov
FDA Decision Cleared SESE
Date Received February 17, 2022
Decision Date October 05, 2023
Days to Decision 595 days
Submission Type Traditional
Review Panel Chemistry (CH)
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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