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FDA 510(k)

MissLan® Early Detection Pregnancy Test Strip; MissLan® Early Detection Pregnancy Test Cassette; MissLan® Early Detection Pregnancy Test Midstream

K-Number: K240643 · 2024-06-21

ApplicantGuangzhou Decheng Biotechnology Co., Ltd.
Decision Date2024-06-21
Product CodeLCX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

MissLan® Early Detection Pregnancy Test Strip; MissLan® Early Detection Pregnancy Test Cassette; MissLan® Early Detection Pregnancy Test Midstream is a medical device manufactured by Guangzhou Decheng Biotechnology Co., Ltd.. It received FDA 510(k) clearance on 2024-06-21 under approval number K240643. 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 Pregnancy Test Strip; MissLan® Early Detection Pregnancy Test Cassette; MissLan® Early Detection Pregnancy Test Midstream?

MissLan® Early Detection Pregnancy Test Strip; MissLan® Early Detection Pregnancy Test Cassette; MissLan® Early Detection Pregnancy Test Midstream is a medical device that received FDA 510(k) clearance on 2024-06-21. It is manufactured by Guangzhou Decheng Biotechnology Co., Ltd.. The 510(k) number is K240643.

When was MissLan® Early Detection Pregnancy Test Strip; MissLan® Early Detection Pregnancy Test Cassette; MissLan® Early Detection Pregnancy Test Midstream approved by the FDA?

MissLan® Early Detection Pregnancy Test Strip; MissLan® Early Detection Pregnancy Test Cassette; MissLan® Early Detection Pregnancy Test Midstream received FDA 510(k) clearance on 2024-06-21, under approval number K240643.

What company makes MissLan® Early Detection Pregnancy Test Strip; MissLan® Early Detection Pregnancy Test Cassette; MissLan® Early Detection Pregnancy Test Midstream?

MissLan® Early Detection Pregnancy Test Strip; MissLan® Early Detection Pregnancy Test Cassette; MissLan® Early Detection Pregnancy Test Midstream is manufactured by Guangzhou Decheng Biotechnology Co., Ltd..

What is the FDA product code for MissLan® Early Detection Pregnancy Test Strip; MissLan® Early Detection Pregnancy Test Cassette; MissLan® Early Detection Pregnancy Test Midstream?

The FDA product code for MissLan® Early Detection Pregnancy Test Strip; MissLan® Early Detection Pregnancy Test Cassette; MissLan® Early Detection Pregnancy Test Midstream is LCX.

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Related PubMed Literature

PMID: 41595987 Recent Advances in AI-Driven Mobile Health Enhancing Healthcare-Narrative Insights into Latest Progress. Bioengineering (Basel, Switzerland) (2025) PMID: 40718881 Advancements in materiovigilance: A comprehensive overview. Perspectives in clinical 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) 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.

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