Cleared Special

PROFILE II ER

K010138 · Medtox Diagnostics, Inc. · Toxicology
Feb 2001
Decision
28d
Days
Class 2
Risk

About This 510(k) Submission

K010138 is an FDA 510(k) clearance for the PROFILE II ER, a Enzyme Immunoassay, Cannabinoids (Class II — Special Controls, product code LDJ), submitted by Medtox Diagnostics, Inc. (Burlington, US). The FDA issued a Cleared decision on February 14, 2001, 28 days after receiving the submission on January 17, 2001. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3870.

Submission Details

510(k) Number K010138 FDA.gov
FDA Decision Cleared SESE
Date Received January 17, 2001
Decision Date February 14, 2001
Days to Decision 28 days
Submission Type Special
Review Panel Toxicology (TX)
Summary Statement

Device Classification

Product Code LDJ — Enzyme Immunoassay, Cannabinoids
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3870

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