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

    ELISA-DOXA SM/RNP

    K Number: K924948 · Decision May 19, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    29
    Registration Numbers
    29
    Same Product Code
    177
    Applicant Total
    8
    Review Days
    231

    Basic Information

    Device Name
    ELISA-DOXA SM/RNP
    K Number
    K924948
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5100
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    ADVANCED BIOLOGICAL PRODUCTS, INC.
    Date Received
    September 30, 1992
    Decision Date
    May 19, 1993
    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 ADVANCED BIOLOGICAL PRODUCTS, INC.

    K Number Device Name
    K924947 ELISA-DOXA SM
    K924945 ELISA-DPXA SSA KIT
    K924950 ELISA-DOXA JO-1
    K924949 ELISA-DOXA SCL-70
    K924952 ELISA-DOXA COMBI-6
    K924951 ELISA-DOXA COMBI-4
    K924946 ELISA-DOXA SSB