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

    SYLNELISA HISTONE ANTIBODIES

    K Number: K932302 · Decision Aug 23, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    18
    Registration Numbers
    18
    Same Product Code
    49
    Applicant Total
    54
    Review Days
    103

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    Basic Information

    Device Name
    SYLNELISA HISTONE ANTIBODIES
    K Number
    K932302
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5100
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Elias U.S.A., Inc.
    Date Received
    May 12, 1993
    Decision Date
    August 23, 1993
    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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    Other Clearances by Elias U.S.A., Inc.

    K Number Device Name
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    K953873 VARELISA HELICOBACTER PYLORI ANTIBODIES
    K953586 VARELISA PR3-ANCA
    K953587 VARELISA MPO-ANCA
    K951187 VARELISA CARDIOLIPIN ABS SCREEN
    K951205 VARELISA ANA PROFILE
    K951206 VARELISA PARIETAL CELL ANTIBODIES
    K951207 VARELISA HISTONE ANTIBODIES
    K944334 VARELISA COMBINED DNA ANTIBODIES EIA
    Search all 54 clearances from Elias U.S.A., Inc. →