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

    DHEA-S

    K Number: K973897 · Decision Nov 13, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    32
    Registration Numbers
    32
    Same Product Code
    27
    Applicant Total
    6
    Review Days
    30

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    Basic Information

    Device Name
    DHEA-S
    K Number
    K973897
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1245
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Kmi Diagnostics, Inc.
    Date Received
    October 14, 1997
    Decision Date
    November 13, 1997
    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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