Hangzhou Clongene Biotech Co., Ltd. · Class II · Cleared Aug 30, 2016
| K-number | K161251 |
| Device name | CLUNGENE Amphetamine Tests, CLUNGENE Cocaine Tests, CLUNGENE Oxazepam Tests |
| Applicant | Hangzhou Clongene Biotech Co., Ltd. |
| Product code | DKZ |
| Device class | Class II |
| Decision date | Aug 30, 2016 |
| Decision | Substantially Equivalent |
| Regulation | 862.3100 |
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