MissLan™ Digital Pregnancy Rapid Test
Kit, Test, Pregnancy, Hcg, Over The Counter
Guangzhou Decheng Biotechnology Co. Ltd.
The following data is part of a premarket notification filed by Guangzhou Decheng Biotechnology Co. Ltd. with the FDA for Misslan™ Digital Pregnancy Rapid Test.
Pre-market Notification Details
| Device ID | K222305 |
| 510k Number | K222305 |
| Device Name: | MissLan™ Digital Pregnancy Rapid Test |
| Classification | Kit, Test, Pregnancy, Hcg, Over The Counter |
| Applicant | Guangzhou Decheng Biotechnology Co. Ltd. Room 107/218/212/405, Building 2, No. 68, 1st Nanxiang Road Science City, Huangpu District Guangzhou, CN 510000 |
| Contact | Weifang Liu |
| 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 | 2022-08-01 |
| Decision Date | 2022-11-30 |
Trademark Results [MissLan]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 MISSLAN 90779167 not registered Live/Pending |
Guangzhou Decheng Biotechnology Co., LTD 2021-06-17 |
 MISSLAN 90470020 not registered Live/Pending |
Yunfei Bai 2021-01-15 |
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