Cleared Traditional

VERDICT -II OPIATES 2000

K992111 · Medtox Diagnostics, Inc. · Toxicology
Dec 1999
Decision
177d
Days
Class 2
Risk

About This 510(k) Submission

K992111 is an FDA 510(k) clearance for the VERDICT -II OPIATES 2000, 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 December 16, 1999, 177 days after receiving the submission on June 22, 1999. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3650.

Submission Details

510(k) Number K992111 FDA.gov
FDA Decision Cleared SESE
Date Received June 22, 1999
Decision Date December 16, 1999
Days to Decision 177 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Statement

Device Classification

Product Code DJG — Enzyme Immunoassay, Opiates
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3650

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