Cleared Traditional

EGENS Urine Test Cup THC-MDMA, EGENS Urine Test DipCard THC-MDMA, EGENS Urine Test Cassette Marijuana

K152643 · Nantong Egens Biotech Co., Ltd. · Toxicology
Nov 2015
Decision
48d
Days
Class 2
Risk

About This 510(k) Submission

K152643 is an FDA 510(k) clearance for the EGENS Urine Test Cup THC-MDMA, EGENS Urine Test DipCard THC-MDMA, EGENS Urine Test Cassette Marijuana, a Enzyme Immunoassay, Cannabinoids (Class II — Special Controls, product code LDJ), submitted by Nantong Egens Biotech Co., Ltd. (Nantong, CN). The FDA issued a Cleared decision on November 2, 2015, 48 days after receiving the submission on September 15, 2015. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3870.

Submission Details

510(k) Number K152643 FDA.gov
FDA Decision Cleared SESE
Date Received September 15, 2015
Decision Date November 02, 2015
Days to Decision 48 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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