BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    SYNELISA DHEA-SULFATE

    K Number: K935469 · Decision Mar 22, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    32
    Registration Numbers
    32
    Same Product Code
    27
    Applicant Total
    54
    Review Days
    139

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    Basic Information

    Device Name
    SYNELISA DHEA-SULFATE
    K Number
    K935469
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1245
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Elias U.S.A., Inc.
    Date Received
    November 3, 1993
    Decision Date
    March 22, 1994
    Product Code
    JKC
    Advisory Committee
    Clinical Chemistry
    Review Advisory Committee
    CH
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    JKC Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate)

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