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

    LA EIA TEST KIT

    K Number: K935419 · Decision May 5, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    25
    Registration Numbers
    25
    Same Product Code
    179
    Applicant Total
    9
    Review Days
    177

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    Basic Information

    Device Name
    LA EIA TEST KIT
    K Number
    K935419
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5100
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    David A. Fuccillo, Ph.D.
    Date Received
    November 9, 1993
    Decision Date
    May 5, 1994
    Product Code
    LLL
    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
    LLL Extractable Antinuclear Antibody, Antigen And Control

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

    K Number Device Name
    K935413 ENA EIA TEST KIT
    K935417 JO-1 EIA TEST KIT
    K935418 SCL-70 EIA TEST KIT
    K940251 MITOCHONDRIA EIA TEST KIT
    K935415 RNP EIA TEST KIT
    K935416 RO EIA TEST KIT
    K935414 SM EIA TEST KIT
    K940253 HISTONE EIA TEST KIT