Cleared Traditional

Healgen MDMA (Ecstacy) Test (Strip, Cassette, Cup, Dip Card), Healgen Phencyclidine Test (Strip, Cassette, Cup, Dip Card)

K150096 · Healgen Scientific, LLC · Toxicology
Mar 2015
Decision
43d
Days
Class 2
Risk

About This 510(k) Submission

K150096 is an FDA 510(k) clearance for the Healgen MDMA (Ecstacy) Test (Strip, Cassette, Cup, Dip Card), Healgen Phencyclidine Test (Strip, Cassette, Cup, Dip Card), a Gas Chromatography, Methamphetamine (Class II — Special Controls, product code LAF), submitted by Healgen Scientific, LLC (Bellaire, US). The FDA issued a Cleared decision on March 4, 2015, 43 days after receiving the submission on January 20, 2015. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3610.

Submission Details

510(k) Number K150096 FDA.gov
FDA Decision Cleared SESE
Date Received January 20, 2015
Decision Date March 04, 2015
Days to Decision 43 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF

Device Classification

Product Code LAF — Gas Chromatography, Methamphetamine
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3610

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