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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