The following data is part of a premarket notification filed by Hangzhou Clongene Biotech Co., Ltd. with the FDA for Clungene Methamphetamine Test, Clungene Morphine Test, Clungene Marijuana Test.
| Device ID | K153741 |
| 510k Number | K153741 |
| Device Name: | CLUNGENE Methamphetamine Test, CLUNGENE Morphine Test, CLUNGENE Marijuana Test |
| Classification | Enzyme Immunoassay, Cannabinoids |
| Applicant | HANGZHOU CLONGENE BIOTECH CO., LTD. BUILDING 4, NO.20 LONGQUAN ROAD YUHANG DISTRICT Hangzhou, CN 311121 |
| Contact | Zheng Shujian |
| Correspondent | Joe Shia LSI INTERNATIONAL INC. 504 E DIAMOND AVE., SUITE I Gaithersburg, MD 20877 |
| Product Code | LDJ |
| Subsequent Product Code | DJC |
| Subsequent Product Code | DJG |
| CFR Regulation Number | 862.3870 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-12-28 |
| Decision Date | 2016-03-18 |
| Summary: | summary |