Cleared Traditional

HEALGEN THC ONE STEP MARIJUANA TEST , HEALGEN MAMP ONE STEP METHAMPHETAMINE TEST

K140546 · Healgen Scientific, LLC · Chemistry
Jun 2014
Decision
94d
Days
Class 2
Risk

About This 510(k) Submission

K140546 is an FDA 510(k) clearance for the HEALGEN THC ONE STEP MARIJUANA TEST , HEALGEN MAMP ONE STEP METHAMPHETAMINE TEST, a Enzyme Immunoassay, Cannabinoids (Class II — Special Controls, product code LDJ), submitted by Healgen Scientific, LLC (Gaithersburg, US). The FDA issued a Cleared decision on June 6, 2014, 94 days after receiving the submission on March 4, 2014. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.3870.

Submission Details

510(k) Number K140546 FDA.gov
FDA Decision Cleared SESE
Date Received March 04, 2014
Decision Date June 06, 2014
Days to Decision 94 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

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

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