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

    MANUAL HER-2/NEU MICROTITER ELISA (OSDI HER-2/NEU ELISA)

    K Number: K994112 · Decision Sep 29, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    2
    Applicant Total
    3
    Review Days
    298

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    Basic Information

    Device Name
    MANUAL HER-2/NEU MICROTITER ELISA (OSDI HER-2/NEU ELISA)
    K Number
    K994112
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.6010
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Oncogene Science, Inc.
    Date Received
    December 6, 1999
    Decision Date
    September 29, 2000
    Product Code
    NCW
    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
    NCW System, Test, Her-2/Neu, Monitoring

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    Other Clearances by Oncogene Science, Inc.

    K Number Device Name
    K002121 TOTAL PSA MICROTITER ELISA
    K002313 COMPLEXED PSA MICROTITER ELISA