The following data is part of a premarket notification filed by Hangzhou Clongene Biotech Co.,ltd. with the FDA for Clungene Hcg Pregnancy Rapid Test Cassette, Clungene Hcg Pregnancy Rapid Test Strip, Clungene Hcg Pregnancy Rapid Test Midstream.
| Device ID | K193132 |
| 510k Number | K193132 |
| Device Name: | CLUNGENE HCG Pregnancy Rapid Test Cassette, CLUNGENE HCG Pregnancy Rapid Test Strip, CLUNGENE HCG Pregnancy Rapid Test Midstream |
| Classification | Kit, Test, Pregnancy, Hcg, 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 | LCX |
| CFR Regulation Number | 862.1155 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-11-12 |
| Decision Date | 2019-12-11 |