The following data is part of a premarket notification filed by Hangzhou Clongene Biotech Co., Ltd with the FDA for Clungene Amphetamine Tests, Clungene Cocaine Tests, Clungene Oxazepam Tests.
| Device ID | K161251 |
| 510k Number | K161251 |
| Device Name: | CLUNGENE Amphetamine Tests, CLUNGENE Cocaine Tests, CLUNGENE Oxazepam Tests |
| Classification | Enzyme Immunoassay, Amphetamine |
| Applicant | Hangzhou Clongene Biotech Co., Ltd Building 4, No. 20 Longquan Road, Yuhang District Hangzhou, CN 311121 |
| Contact | Zheng Shujian |
| Correspondent | Jesse Xia LSI International 504 E Diamond Ave., Suite I Gaithersburg, MD 20877 |
| Product Code | DKZ |
| Subsequent Product Code | DIO |
| Subsequent Product Code | JXM |
| CFR Regulation Number | 862.3100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-05-03 |
| Decision Date | 2016-08-30 |
| Summary: | summary |