Cleared Traditional

OralTox Oral fluid Drug Test

K181305 · Premier Biotech, Inc. · Toxicology
Sep 2018
Decision
126d
Days
Class 2
Risk

About This 510(k) Submission

K181305 is an FDA 510(k) clearance for the OralTox Oral fluid Drug Test, a Thin Layer Chromatography, Methamphetamine (Class II — Special Controls, product code DJC), submitted by Premier Biotech, Inc. (Minneapolis, US). The FDA issued a Cleared decision on September 20, 2018, 126 days after receiving the submission on May 17, 2018. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3610.

Submission Details

510(k) Number K181305 FDA.gov
FDA Decision Cleared SESE
Date Received May 17, 2018
Decision Date September 20, 2018
Days to Decision 126 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF

Device Classification

Product Code DJC — Thin Layer Chromatography, Methamphetamine
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3610

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