BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇨🇳 China

    Clungene RSV Antigen Rapid Test

    K Number: K253318 · Decision Jan 30, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    35
    Registration Numbers
    35
    Same Product Code
    31
    Applicant Total
    9
    Review Days
    122

    Basic Information

    Device Name
    Clungene RSV Antigen Rapid Test
    K Number
    K253318
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.3480
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Hangzhou Clongene Biotech Co., Ltd.
    Date Received
    September 30, 2025
    Decision Date
    January 30, 2026
    Product Code
    GQG
    Advisory Committee
    Microbiology
    Review Advisory Committee
    MI
    Third Party
    N

    Classifications

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

    Product Code Device Name
    GQG Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus

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