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

    MODIFICATION TO BIOSTAR OIA SHIGATOX

    K Number: K071799 · Decision Oct 2, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    12
    Registration Numbers
    12
    Same Product Code
    11
    Applicant Total
    1
    Review Days
    92

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    Basic Information

    Device Name
    MODIFICATION TO BIOSTAR OIA SHIGATOX
    K Number
    K071799
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.3255
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Iverness Medical Professional Diagnostics
    Date Received
    July 2, 2007
    Decision Date
    October 2, 2007
    Product Code
    GNA
    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
    GNA Antisera, All Types, Escherichia Coli

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