Cleared Traditional

PROFILE-ER

K002331 · Medtox Diagnostics, Inc. · Toxicology
Jan 2001
Decision
169d
Days
Class 2
Risk

About This 510(k) Submission

K002331 is an FDA 510(k) clearance for the PROFILE-ER, 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 January 17, 2001, 169 days after receiving the submission on August 1, 2000. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3150.

Submission Details

510(k) Number K002331 FDA.gov
FDA Decision Cleared SESE
Date Received August 01, 2000
Decision Date January 17, 2001
Days to Decision 169 days
Submission Type Traditional
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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