BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    Curian® Shiga Toxin

    K Number: K222829 · Decision Apr 17, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    10
    Registration Numbers
    10
    Same Product Code
    13
    Applicant Total
    38
    Review Days
    210

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    Basic Information

    Device Name
    Curian® Shiga Toxin
    K Number
    K222829
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.3255
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Meridian Bioscience, Inc.
    Date Received
    September 19, 2022
    Decision Date
    April 17, 2023
    Product Code
    GMZ
    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
    GMZ Antigens, All Types, Escherichia Coli

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