Cleared Traditional

MEDTOX BUPRENORPHINE TEST

K100951 · Medtox Diagnostics, Inc. · Chemistry
Oct 2010
Decision
195d
Days
Class 2
Risk

About This 510(k) Submission

K100951 is an FDA 510(k) clearance for the MEDTOX BUPRENORPHINE TEST, a Enzyme Immunoassay, Opiates (Class II — Special Controls, product code DJG), submitted by Medtox Diagnostics, Inc. (Burlington, US). The FDA issued a Cleared decision on October 18, 2010, 195 days after receiving the submission on April 6, 2010. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.3650.

Submission Details

510(k) Number K100951 FDA.gov
FDA Decision Cleared SESE
Date Received April 06, 2010
Decision Date October 18, 2010
Days to Decision 195 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code DJG — Enzyme Immunoassay, Opiates
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3650

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