Cleared Traditional

ADVANTAGE MARIJUANA (THC) AND COCAINE HOME DRUG TEST

K011962 · Advantage Diagnostics Corp. · Toxicology
Aug 2001
Decision
48d
Days
Class 2
Risk

About This 510(k) Submission

K011962 is an FDA 510(k) clearance for the ADVANTAGE MARIJUANA (THC) AND COCAINE HOME DRUG TEST, a Enzyme Immunoassay, Cocaine And Cocaine Metabolites (Class II — Special Controls, product code DIO), submitted by Advantage Diagnostics Corp. (Chard, Somerset, GB). The FDA issued a Cleared decision on August 9, 2001, 48 days after receiving the submission on June 22, 2001. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3250.

Submission Details

510(k) Number K011962 FDA.gov
FDA Decision Cleared SESE
Date Received June 22, 2001
Decision Date August 09, 2001
Days to Decision 48 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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