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

    Babio® Virus Transport Kit (Non-inactivating)

    K Number: K250205 · Decision Sep 22, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    74
    Registration Numbers
    74
    Same Product Code
    110
    Applicant Total
    1
    Review Days
    241

    Basic Information

    Device Name
    Babio® Virus Transport Kit (Non-inactivating)
    K Number
    K250205
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.2390
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Jinan Babio Biotechnology Co., Ltd.
    Date Received
    January 24, 2025
    Decision Date
    September 22, 2025
    Product Code
    JSM
    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
    JSM Culture Media, Non-Propagating Transport

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