Cleared Special

VERDICT -II TCA, VERDICT-II MTD

K011545 · Medtox Diagnostics, Inc. · Toxicology
Jun 2001
Decision
21d
Days
Class 2
Risk

About This 510(k) Submission

K011545 is an FDA 510(k) clearance for the VERDICT -II TCA, VERDICT-II MTD, a Radioimmunoassay, Tricyclic Antidepressant Drugs (Class II — Special Controls, product code LFG), submitted by Medtox Diagnostics, Inc. (Burlington, US). The FDA issued a Cleared decision on June 8, 2001, 21 days after receiving the submission on May 18, 2001. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3910.

Submission Details

510(k) Number K011545 FDA.gov
FDA Decision Cleared SESE
Date Received May 18, 2001
Decision Date June 08, 2001
Days to Decision 21 days
Submission Type Special
Review Panel Toxicology (TX)
Summary Statement

Device Classification

Product Code LFG — Radioimmunoassay, Tricyclic Antidepressant Drugs
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3910
Definition Intended To Measure Any Of The Tricyclic Antidepressant Drugs In Serum Or Urine.

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