Cleared Traditional

ADVANTAGE MULTIPLE DRUGS OF ABUSE TEST

K023712 · Advantage Diagnostics Corp. · Toxicology
Jan 2003
Decision
88d
Days
Class 2
Risk

About This 510(k) Submission

K023712 is an FDA 510(k) clearance for the ADVANTAGE MULTIPLE DRUGS OF ABUSE TEST, a Enzyme Immunoassay, Amphetamine (Class II — Special Controls, product code DKZ), submitted by Advantage Diagnostics Corp. (Sunnyvale, US). The FDA issued a Cleared decision on January 31, 2003, 88 days after receiving the submission on November 4, 2002. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3100.

Submission Details

510(k) Number K023712 FDA.gov
FDA Decision Cleared SESE
Date Received November 04, 2002
Decision Date January 31, 2003
Days to Decision 88 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF

Device Classification

Product Code DKZ — Enzyme Immunoassay, Amphetamine
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3100

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