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® Pregnancy Rapid Test (Strip), MissLan® Pregnancy Rapid Test (Midstream)

K-Number: K230038 · 2023-02-28

ApplicantGuangzhou Decheng Biotechnology Co., Ltd.
Decision Date2023-02-28
Product CodeLCX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

MissLan® Pregnancy Rapid Test (Strip), MissLan® Pregnancy Rapid Test (Midstream) is a medical device manufactured by Guangzhou Decheng Biotechnology Co., Ltd.. It received FDA 510(k) clearance on 2023-02-28 under approval number K230038. 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® Pregnancy Rapid Test (Strip), MissLan® Pregnancy Rapid Test (Midstream)?

MissLan® Pregnancy Rapid Test (Strip), MissLan® Pregnancy Rapid Test (Midstream) is a medical device that received FDA 510(k) clearance on 2023-02-28. It is manufactured by Guangzhou Decheng Biotechnology Co., Ltd.. The 510(k) number is K230038.

When was MissLan® Pregnancy Rapid Test (Strip), MissLan® Pregnancy Rapid Test (Midstream) approved by the FDA?

MissLan® Pregnancy Rapid Test (Strip), MissLan® Pregnancy Rapid Test (Midstream) received FDA 510(k) clearance on 2023-02-28, under approval number K230038.

What company makes MissLan® Pregnancy Rapid Test (Strip), MissLan® Pregnancy Rapid Test (Midstream)?

MissLan® Pregnancy Rapid Test (Strip), MissLan® Pregnancy Rapid Test (Midstream) is manufactured by Guangzhou Decheng Biotechnology Co., Ltd..

What is the FDA product code for MissLan® Pregnancy Rapid Test (Strip), MissLan® Pregnancy Rapid Test (Midstream)?

The FDA product code for MissLan® Pregnancy Rapid Test (Strip), MissLan® Pregnancy Rapid Test (Midstream) is LCX.

Related Clinical Trials

NCT06645106 Offering Routine and Rapid Point of Care (POC) Syphilis Testing in Pregnant Patients Presenting to the Emergency Department RECRUITING NCT04762316 Composition for Treating Uterine Fibroid (SB-UF) COMPLETED NCT07498153 Spotting Syphilis: A Dual Point-of-Care Syphilis Screening Initiative in a Low-Resource Healthcare Setting COMPLETED

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 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.

↑