FDA 510(k) Applications Submitted by Zheng Shujian
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K180255 |
01/30/2018 |
CLUNGENE Multi-Drug Test Dip Card, CLUNGENE Multi-Drug Test Easy Cup |
Hangzhou Clongene Biotech Co.,Ltd. |
| K190412 |
02/21/2019 |
CLUNGENE Multi-Drug Test Dip Card, CLUNGENE Multi-Drug Test Easy Cup |
Hangzhou Clongene Biotech Co.,Ltd. |
| K161251 |
05/03/2016 |
CLUNGENE Amphetamine Tests, CLUNGENE Cocaine Tests, CLUNGENE Oxazepam Tests |
Hangzhou Clongene Biotech Co., Ltd |
| K181790 |
07/05/2018 |
CLUNGENE Multi-Drug Test Dip Card, CLUNGENE Multi-Drug Test Easy Cup |
Hangzhou Clongene Biotech Co.,Ltd. |
| K193132 |
11/12/2019 |
CLUNGENE HCG Pregnancy Rapid Test Cassette, CLUNGENE HCG Pregnancy Rapid Test Strip, CLUNGENE HCG Pregnancy Rapid Test Midstream |
Hangzhou Clongene Biotech Co.,Ltd. |
| K153741 |
12/28/2015 |
CLUNGENE Methamphetamine Test, CLUNGENE Morphine Test, CLUNGENE Marijuana Test |
HANGZHOU CLONGENE BIOTECH CO., LTD. |
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