Cleared Special

PROFILE -ER

K033334 · Medtox Diagnostics, Inc. · Toxicology
Nov 2003
Decision
25d
Days
Class 2
Risk

About This 510(k) Submission

K033334 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 November 10, 2003, 25 days after receiving the submission on October 16, 2003. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3150.

Submission Details

510(k) Number K033334 FDA.gov
FDA Decision Cleared SESE
Date Received October 16, 2003
Decision Date November 10, 2003
Days to Decision 25 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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