FDA 510(k)

MissLan Digital Pregnancy Rapid Test

K-Number: K222305 · 2022-11-30

ApplicantGuangzhou Decheng Biotechnology Co., Ltd.

Decision Date2022-11-30

Product CodeLCX

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

MissLan Digital Pregnancy Rapid Test is a medical device manufactured by Guangzhou Decheng Biotechnology Co., Ltd.. It received FDA 510(k) clearance on 2022-11-30 under approval number K222305. The device is classified under product code LCX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MissLan Digital Pregnancy Rapid Test?

MissLan Digital Pregnancy Rapid Test is a medical device that received FDA 510(k) clearance on 2022-11-30. It is manufactured by Guangzhou Decheng Biotechnology Co., Ltd.. The 510(k) number is K222305.

When was MissLan Digital Pregnancy Rapid Test approved by the FDA?

MissLan Digital Pregnancy Rapid Test received FDA 510(k) clearance on 2022-11-30, under approval number K222305.

What company makes MissLan Digital Pregnancy Rapid Test?

MissLan Digital Pregnancy Rapid Test is manufactured by Guangzhou Decheng Biotechnology Co., Ltd..

What is the FDA product code for MissLan Digital Pregnancy Rapid Test?

The FDA product code for MissLan Digital Pregnancy Rapid Test is LCX.

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Related PubMed Literature

PMID: 42145202 Fertile-window misclassification in period-tracking applications and associated pregnancy risk: a large observational analysis. The European journal of contraception & reproductive health care : the official journal of the European Society of Contraception (2026) PMID: 41982627 Cybersecurity breaches in medical devices: analyzing FDA safety communications in response to patient security concerns. Frontiers in digital health (2026) PMID: 41437380 Applications of artificial intelligence in non-small cell lung cancer: from precision diagnosis to personalized prognosis and therapy. Journal of translational medicine (2025) PMID: 40424619 Digital Therapeutics in China: Comprehensive Review. Journal of medical Internet research (2025)

Other Devices by Guangzhou Decheng Biotechnology Co., Ltd.

K232659Dochek® Multi-Drug Urine Test Cup Rx, Dochek® Multi-Drug Urine Test Cup K230038MissLan® Pregnancy Rapid Test (Strip), MissLan® Pregnancy Rapid Test (Midstream) K240643MissLan® Early Detection Pregnancy Test Strip; MissLan® Early Detection Pregnancy Test Cassette; MissLan® Early Detection Pregnancy Test Midstream K240698Dochek® Multi-Drug Urine Test Dipcard Rx; Dochek® Multi-Drug Urine Test Dipcard K251040MissLan® Early Detection Digital Pregnancy Test; MissLan® Early Result Digital Pregnancy Test K250067Dochek® Multi-Drug Urine Test Cup; Dochek® Multi-Drug Urine Test Cup Pro

View all 8 devices →

Related Devices (Code: LCX)

K142754Surearly Pregnancy Test Strip, Surearly Digital Pregnancy TestSugentech, Inc. K171136LIA Pregnancy TestLia Diagnostics K180771Acro HCG Pregnancy Rapid TestAcro Biotech, Inc. K172627David Home Pregnancy Test Cassette, David Professional Pregnancy Test CassetteRunbio Biotech Co.,Ltd K173229Preview Digital Pregnancy TestGuangzhou Wondfo Biotech Co., Ltd. K172512ACRO HCG Pregnancy Rapid TestAcro Biotech, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.