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

    COXSACKIEVIRUS B5 MONOCLONAL ANTIBODY

    K Number: K940472 · Decision Sep 8, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    8
    Applicant Total
    8
    Review Days
    583

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    Basic Information

    Device Name
    COXSACKIEVIRUS B5 MONOCLONAL ANTIBODY
    K Number
    K940472
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.3145
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Chemicon Intl., Inc.
    Date Received
    February 2, 1994
    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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    Other Clearances by Chemicon Intl., Inc.

    K Number Device Name
    K992252 LIGHT DIAGNOSTICS PNEUMOCYSTIS CARINII DFA, MODEL 31965
    K940027 ENTEROVIRUS BLEND MONOCLONAL ANTIBODIES
    K940473 ENTEROVIRUS 71 MONOCLONAL ANTIBODY
    K936089 COXSACKIE A24 VIRUS MONOCLONAL ANTIBODY
    K936073 ENTEROVIRUS MONOCL ANTIBODY DET OF COXSACKIE A9 VIRUS
    K940471 COXSACKIEVIRUS B BLEND MONOCLONAL ANTIBODIES
    K936145 COXSACKIEVIRUS B1 MONOCLONAL ANTIBODY