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

    MITOCHONDRIA EIA TEST KIT

    K Number: K940251 · Decision May 3, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    15
    Registration Numbers
    15
    Same Product Code
    26
    Applicant Total
    9
    Review Days
    104

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    Basic Information

    Device Name
    MITOCHONDRIA EIA TEST KIT
    K Number
    K940251
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5090
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    David A. Fuccillo, Ph.D.
    Date Received
    January 19, 1994
    Decision Date
    May 3, 1994
    Product Code
    DBM
    Advisory Committee
    Immunology
    Review Advisory Committee
    IM
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    DBM Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control

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    Other Clearances by David A. Fuccillo, Ph.D.

    K Number Device Name
    K935413 ENA EIA TEST KIT
    K935419 LA EIA TEST KIT
    K935417 JO-1 EIA TEST KIT
    K935418 SCL-70 EIA TEST KIT
    K935415 RNP EIA TEST KIT
    K935416 RO EIA TEST KIT
    K935414 SM EIA TEST KIT
    K940253 HISTONE EIA TEST KIT