Cleared Traditional

DRI Cocaine Metabolite Assay

K181499 · Microgenics Corporation · Toxicology
Jul 2018
Decision
29d
Days
Class 2
Risk

About This 510(k) Submission

K181499 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 July 6, 2018, 29 days after receiving the submission on June 7, 2018. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3250.

Submission Details

510(k) Number K181499 FDA.gov
FDA Decision Cleared SESE
Date Received June 07, 2018
Decision Date July 06, 2018
Days to Decision 29 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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