Cleared Special

VERDICT -II BAR; VERDICT -II BZO

K010959 · Medtox Diagnostics, Inc. · Toxicology
Apr 2001
Decision
14d
Days
Class 2
Risk

About This 510(k) Submission

K010959 is an FDA 510(k) clearance for the VERDICT -II BAR; VERDICT -II BZO, a Enzyme Immunoassay, Barbiturate (Class II — Special Controls, product code DIS), submitted by Medtox Diagnostics, Inc. (Burlington, US). The FDA issued a Cleared decision on April 13, 2001, 14 days after receiving the submission on March 30, 2001. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3150.

Submission Details

510(k) Number K010959 FDA.gov
FDA Decision Cleared SESE
Date Received March 30, 2001
Decision Date April 13, 2001
Days to Decision 14 days
Submission Type Special
Review Panel Toxicology (TX)
Summary Statement

Device Classification

Product Code DIS — Enzyme Immunoassay, Barbiturate
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3150

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