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

    THE THERATEST EL-ANA PROFILES

    K Number: K914454 · Decision May 22, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    18
    Registration Numbers
    18
    Same Product Code
    49
    Applicant Total
    22
    Review Days
    228

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    Basic Information

    Device Name
    THE THERATEST EL-ANA PROFILES
    K Number
    K914454
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5100
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Theratest Laboratories, Inc.
    Date Received
    October 7, 1991
    Decision Date
    May 22, 1992
    Product Code
    LKJ
    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
    LKJ Antinuclear Antibody, Antigen, Control

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    K071692 THERATEST EL-TTG IGA/IGG AND THERATEST EL-GLIA IGA/IGG TEST SYSTEMS
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    K060176 EL-ACL SCREEN; EL-ACL IGM, IGG, IGA
    K051066 THERATEST EL-ANA PROFILES
    K040291 EL-ANA PROFILES: ANTI-CHROMATIN
    K024031 THE THERATEST EL-ANA PROFILES: ANTI-CENTROMERE
    K024151 EL-ANA PROFILES: ANTI-RIBOSOMAL PROTEIN P
    K002559 EL-ANA PROFILES-2K1
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