The following data is part of a premarket notification filed by Hangzhou Clongene Biotech Co.,ltd. with the FDA for Clungene Multi-drug Test Dip Card, Clungene Multi-drug Test Easy Cup.
| Device ID | K190412 |
| 510k Number | K190412 |
| Device Name: | CLUNGENE Multi-Drug Test Dip Card, CLUNGENE Multi-Drug Test Easy Cup |
| Classification | Test, Opiates, Over The Counter |
| 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 504 E Diamond Ave., Suite I Gaithersburg, MD 20877 |
| Product Code | NGL |
| Subsequent Product Code | PTG |
| Subsequent Product Code | QBF |
| CFR Regulation Number | 862.3650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-02-21 |
| Decision Date | 2019-03-21 |
| Summary: | summary |