Cleared Traditional

DRI Cocaine Metabolite Assay

K211973 · Microgenics Corporation · Toxicology
Sep 2021
Decision
91d
Days
Class 2
Risk

About This 510(k) Submission

K211973 is an FDA 510(k) clearance for the DRI Cocaine Metabolite Assay, a Enzyme Immunoassay, Cocaine And Cocaine Metabolites (Class II — Special Controls, product code DIO), submitted by Microgenics Corporation (Fremond, US). The FDA issued a Cleared decision on September 24, 2021, 91 days after receiving the submission on June 25, 2021. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3250.

Submission Details

510(k) Number K211973 FDA.gov
FDA Decision Cleared SESE
Date Received June 25, 2021
Decision Date September 24, 2021
Days to Decision 91 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF

Device Classification

Product Code DIO — Enzyme Immunoassay, Cocaine And Cocaine Metabolites
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3250

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