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

    HYDRAGAMMA 16

    K Number: K800601 · Decision Apr 10, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    62
    Applicant Total
    28
    Review Days
    24

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    Basic Information

    Device Name
    HYDRAGAMMA 16
    K Number
    K800601
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.2320
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Innotron of Oregon, Inc.
    Date Received
    March 17, 1980
    Decision Date
    April 10, 1980
    Product Code
    JJJ
    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
    JJJ Counter (Beta, Gamma) For Clinical Use

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