FDA 510(k) Applications for Medical Device Product Code "NGL"
(Test, Opiates, Over The Counter)

FDA 510(k) Number Applicant Device Name Decision Date
K082898 AMEDICA BIOTECH, INC. AMEDICA DRUG SCREEN TEST CUP 12/19/2008
K100108 AMEDICA BIOTECH, INC. AMEDICA DRUG TEST THC, COC, OPI, AMP, MET, PCP, BAR, BZO, MDMA, OXY, TCA 04/14/2010
K181790 Hangzhou Clongene Biotech Co.,Ltd. CLUNGENE Multi-Drug Test Dip Card, CLUNGENE Multi-Drug Test Easy Cup 07/26/2018
K190412 Hangzhou Clongene Biotech Co.,Ltd. CLUNGENE Multi-Drug Test Dip Card, CLUNGENE Multi-Drug Test Easy Cup 03/21/2019
K193480 Shenzhen Bioeasy Biotechnology Co.,Ltd. BIOEASY Multi-Drug Test Cup 01/31/2020


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