Cleared Traditional

AssureTech Methamphetamine Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup), AssureTech Phencyclidine Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup), AssureTech Marijuana Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup)

K161044 · Assure Tech. (Hangzhou) Co, Ltd. · Toxicology
Jul 2016
Decision
84d
Days
Class 2
Risk

About This 510(k) Submission

K161044 is an FDA 510(k) clearance for the AssureTech Methamphetamine Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup), AssureTech Phencyclidine Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup), AssureTech Marijuana Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup), a Thin Layer Chromatography, Methamphetamine (Class II — Special Controls, product code DJC), submitted by Assure Tech. (Hangzhou) Co, Ltd. (Hangzhou, CN). The FDA issued a Cleared decision on July 6, 2016, 84 days after receiving the submission on April 13, 2016. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3610.

Submission Details

510(k) Number K161044 FDA.gov
FDA Decision Cleared SESE
Date Received April 13, 2016
Decision Date July 06, 2016
Days to Decision 84 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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