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

    KETOSTEROID TEST, HYCEL-17

    K Number: K782116 · Decision Jan 26, 1979
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    0
    Applicant Total
    22
    Review Days
    30

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    Basic Information

    Device Name
    KETOSTEROID TEST, HYCEL-17
    K Number
    K782116
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.1430
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Hycel, Inc.
    Date Received
    December 27, 1978
    Decision Date
    January 26, 1979
    Product Code
    CCY
    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
    CCY Zimmerman (Spectrophotometric), 17-Ketosteroids

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