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

    RIBOSOMAL P EIA TEST SYSTEM

    K Number: K950169 · Decision May 23, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    3
    Applicant Total
    26
    Review Days
    492

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    Basic Information

    Device Name
    RIBOSOMAL P EIA TEST SYSTEM
    K Number
    K950169
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5100
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Hogan & Hartson
    Date Received
    January 17, 1995
    Decision Date
    May 23, 1996
    Product Code
    MQA
    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
    MQA Anti-Ribosomal P Antibodies

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