Cleared Special

VERDICT -II THC/COC/OPI/AMP/PCP/BAR/BZO & THC/COC/BAR/BZO; PROFILE -II 7 THC/COC/OPI/AMP/PCP/BAR/BZO

K010564 · Medtox Diagnostics, Inc. · Toxicology
Apr 2001
Decision
38d
Days
Class 2
Risk

About This 510(k) Submission

K010564 is an FDA 510(k) clearance for the VERDICT -II THC/COC/OPI/AMP/PCP/BAR/BZO & THC/COC/BAR/BZO; PROFILE -II 7 THC/COC/OPI/AMP/PCP/BAR/BZO, a Enzyme Immunoassay, Amphetamine (Class II — Special Controls, product code DKZ), submitted by Medtox Diagnostics, Inc. (Burlington, US). The FDA issued a Cleared decision on April 5, 2001, 38 days after receiving the submission on February 26, 2001. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3100.

Submission Details

510(k) Number K010564 FDA.gov
FDA Decision Cleared SESE
Date Received February 26, 2001
Decision Date April 05, 2001
Days to Decision 38 days
Submission Type Special
Review Panel Toxicology (TX)
Summary Statement

Device Classification

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

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