Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

MissLan® Early Detection Digital Pregnancy Test; MissLan® Early Result Digital Pregnancy Test

K-Number: K251040 · 2025-09-09

ApplicantGuangzhou Decheng Biotechnology Co., Ltd.
Decision Date2025-09-09
Product CodeLCX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

MissLan® Early Detection Digital Pregnancy Test; MissLan® Early Result Digital Pregnancy Test is a medical device manufactured by Guangzhou Decheng Biotechnology Co., Ltd.. It received FDA 510(k) clearance on 2025-09-09 under approval number K251040. 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® Early Detection Digital Pregnancy Test; MissLan® Early Result Digital Pregnancy Test?

MissLan® Early Detection Digital Pregnancy Test; MissLan® Early Result Digital Pregnancy Test is a medical device that received FDA 510(k) clearance on 2025-09-09. It is manufactured by Guangzhou Decheng Biotechnology Co., Ltd.. The 510(k) number is K251040.

When was MissLan® Early Detection Digital Pregnancy Test; MissLan® Early Result Digital Pregnancy Test approved by the FDA?

MissLan® Early Detection Digital Pregnancy Test; MissLan® Early Result Digital Pregnancy Test received FDA 510(k) clearance on 2025-09-09, under approval number K251040.

What company makes MissLan® Early Detection Digital Pregnancy Test; MissLan® Early Result Digital Pregnancy Test?

MissLan® Early Detection Digital Pregnancy Test; MissLan® Early Result Digital Pregnancy Test is manufactured by Guangzhou Decheng Biotechnology Co., Ltd..

What is the FDA product code for MissLan® Early Detection Digital Pregnancy Test; MissLan® Early Result Digital Pregnancy Test?

The FDA product code for MissLan® Early Detection Digital Pregnancy Test; MissLan® Early Result Digital Pregnancy Test is LCX.

Related Clinical Trials

NCT07613658 3D-Printed Versus Band-and-Loop Versus Denovo Space Maintainers in Primary Dentition. NOT_YET_RECRUITING NCT07613775 Volume-Stable Collagen Matrix Versus Subepithelial Connective Tissue Graft for Multiple Gingival Recessions NOT_YET_RECRUITING NCT01212926 Early Detection of Anthracycline Cardiotoxicity by Echocardiographic Analysis of Myocardial Deformation in 2D Strain COMPLETED NCT07284511 A Clinical Trial Using Tirzepatide to Help Adults With Type 1 Diabetes Automatically Control Their Blood Sugar RECRUITING NCT06099795 Evaluation of Concordance Between Exhaled Air Test (eBAM-CoV) and RT-PCR to Detect SARS-CoV-2 RECRUITING NCT07592481 Connected Blood Pressure Monitoring in Patients With Hematologic Malignancies Initiating Covalent BTK Inhibitors NOT_YET_RECRUITING

Related PubMed Literature

PMID: 42204020 A Minimal UDI-DICOM Mapping Profile and Validation Artifact for Medical-Device Imaging Workflows. Journal of imaging informatics in medicine (2026) 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: 41595987 Recent Advances in AI-Driven Mobile Health Enhancing Healthcare-Narrative Insights into Latest Progress. Bioengineering (Basel, Switzerland) (2025) PMID: 41032887 Stakeholder Perspectives on Early Feasibility Studies for Digital Health Technologies in the European Union: Qualitative Interview Study. Journal of medical Internet research (2025)

Other Devices by Guangzhou Decheng Biotechnology Co., Ltd.

K222305MissLan™ Digital Pregnancy Rapid Test 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 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.

↑