Cleared Traditional

MEDTOX OXYCODONE

K060351 · Medtox Diagnostics, Inc. · Toxicology
May 2006
Decision
88d
Days
Class 2
Risk

About This 510(k) Submission

K060351 is an FDA 510(k) clearance for the MEDTOX OXYCODONE, a Enzyme Immunoassay, Opiates (Class II — Special Controls, product code DJG), submitted by Medtox Diagnostics, Inc. (Burlington, US). The FDA issued a Cleared decision on May 12, 2006, 88 days after receiving the submission on February 13, 2006. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3650.

Submission Details

510(k) Number K060351 FDA.gov
FDA Decision Cleared SESE
Date Received February 13, 2006
Decision Date May 12, 2006
Days to Decision 88 days
Submission Type Traditional
Review Panel Toxicology (TX)
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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