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

    KEMTEK 103 RIA GAMMA COUNTER

    K Number: K832735 · Decision Sep 29, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    62
    Applicant Total
    9
    Review Days
    56

    Basic Information

    Device Name
    KEMTEK 103 RIA GAMMA COUNTER
    K Number
    K832735
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.2320
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    KEMBLE INSTRUMENTS, INC.
    Date Received
    August 4, 1983
    Decision Date
    September 29, 1983
    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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