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

    VARELISA COMBINED DNA ANTIBODIES EIA

    K Number: K944334 · Decision Apr 17, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    14
    Registration Numbers
    14
    Same Product Code
    28
    Applicant Total
    54
    Review Days
    223

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    Basic Information

    Device Name
    VARELISA COMBINED DNA ANTIBODIES EIA
    K Number
    K944334
    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
    September 6, 1994
    Decision Date
    April 17, 1995
    Product Code
    LRM
    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
    LRM Anti-Dna Antibody (Enzyme-Labeled), Antigen, Control

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    Other Clearances by Elias U.S.A., Inc.

    K Number Device Name
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    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
    K951186 VARELISA ANA-4 SCREEN
    Search all 54 clearances from Elias U.S.A., Inc. →