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

    COCKSACKIEVIRUS B6 MONOCLONAL ANTIBODY

    K Number: K936254 · Decision Sep 8, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    8
    Applicant Total
    19
    Review Days
    617

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    Basic Information

    Device Name
    COCKSACKIEVIRUS B6 MONOCLONAL ANTIBODY
    K Number
    K936254
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.3145
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Light Diagnostics
    Date Received
    December 30, 1993
    Decision Date
    September 8, 1995
    Product Code
    GNM
    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
    GNM Antisera, Fluorescent, Coxsackievirus A 1-24, B 1-6

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