BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    MMUNO DOT BORRELIA DOT BLOT M TEST

    K Number: K953683 · Decision May 3, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    30
    Registration Numbers
    30
    Same Product Code
    110
    Applicant Total
    10
    Review Days
    270

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    Basic Information

    Device Name
    MMUNO DOT BORRELIA DOT BLOT M TEST
    K Number
    K953683
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3830
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Genbio
    Date Received
    August 7, 1995
    Decision Date
    May 3, 1996
    Product Code
    LSR
    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
    LSR Reagent, Borrelia Serological Reagent

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