BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇳 China

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

    K Number: K251040 · Decision Sep 9, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    117
    Registration Numbers
    117
    Same Product Code
    225
    Applicant Total
    8
    Review Days
    159

    Basic Information

    Device Name
    MissLan® Early Detection Digital Pregnancy Test; MissLan® Early Result Digital Pregnancy Test
    K Number
    K251040
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1155
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Guangzhou Decheng Biotechnology Co., Ltd.
    Date Received
    April 3, 2025
    Decision Date
    September 9, 2025
    Product Code
    LCX
    Advisory Committee
    Clinical Chemistry
    Review Advisory Committee
    CH
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    LCX Kit, Test, Pregnancy, Hcg, Over The Counter

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (LCX), ordered by most recent decision date.

    Shinetell PlusTM Digital Early Pregnancy Test

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    FaStep Pregnancy Rapid Test Cassette; Fastep HCG Rapid Test Cassette

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Synthgene Home Test HCG Test Strip; Synthgene Home Test HCG Test Cassette; Synthgene Home Test HCG Test Midstream

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    FaStep Early Pregnancy Rapid Test Strip; FaStep Early Pregnancy Rapid Test Cassette; FaStep Early Pregnancy Rapid Test Midstream

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    iHealth® Early Pregnancy Test; iHealth® Early Pregnancy Test Strip

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    HCG Home Use Pregnancy Test Strip (Colloidal Gold), HCG Home Use Pregnancy Test Cassette (Colloidal Gold), HCG Home Use Pregnancy Test Midstream (Colloidal Gold)

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry
    View all

    Other Clearances by Guangzhou Decheng Biotechnology Co., Ltd.

    K Number Device Name
    K250067 Dochek® Multi-Drug Urine Test Cup; Dochek® Multi-Drug Urine Test Cup Pro
    K242428 Dochek® Fentanyl Urine Test Strip, Dochek® Fentanyl Urine Test Strip Plus, Dochek® Fentanyl Urine Test Card, Dochek® Fentanyl Urine Test Card Plus, Dochek® Fentanyl Urine Test Cup and Dochek® Fentanyl Urine Test Cup Plus
    K240643 MissLan® Early Detection Pregnancy Test Strip; MissLan® Early Detection Pregnancy Test Cassette; MissLan® Early Detection Pregnancy Test Midstream
    K240698 Dochek® Multi-Drug Urine Test Dipcard Rx; Dochek® Multi-Drug Urine Test Dipcard
    K232659 Dochek® Multi-Drug Urine Test Cup Rx, Dochek® Multi-Drug Urine Test Cup
    K230038 MissLan® Pregnancy Rapid Test (Strip), MissLan® Pregnancy Rapid Test (Midstream)
    K222305 MissLan™ Digital Pregnancy Rapid Test