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

    DUOPATH VEROTOXINS GLISA TEST

    K Number: K031367 · Decision Jan 23, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    12
    Registration Numbers
    12
    Same Product Code
    11
    Applicant Total
    62
    Review Days
    268

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    Basic Information

    Device Name
    DUOPATH VEROTOXINS GLISA TEST
    K Number
    K031367
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.3255
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Emd Chemicals, Inc.
    Date Received
    April 30, 2003
    Decision Date
    January 23, 2004
    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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