Cleared Traditional

CLUNGENE Methamphetamine Test, CLUNGENE Morphine Test, CLUNGENE Marijuana Test

K153741 · Hangzhou Clongene Biotech Co., Ltd. · Toxicology
Mar 2016
Decision
81d
Days
Class 2
Risk

About This 510(k) Submission

K153741 is an FDA 510(k) clearance for the CLUNGENE Methamphetamine Test, CLUNGENE Morphine Test, CLUNGENE Marijuana Test, a Enzyme Immunoassay, Cannabinoids (Class II — Special Controls, product code LDJ), submitted by Hangzhou Clongene Biotech Co., Ltd. (Hangzhou, CN). The FDA issued a Cleared decision on March 18, 2016, 81 days after receiving the submission on December 28, 2015. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3870.

Submission Details

510(k) Number K153741 FDA.gov
FDA Decision Cleared SESE
Date Received December 28, 2015
Decision Date March 18, 2016
Days to Decision 81 days
Submission Type Traditional
Review Panel Toxicology (TX)
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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