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

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
30850054867392	K222305	000
00850054867384	K222305	000
00383173000450	K222305	000
00860011389200	K222305	000