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

    NML 5000 AUTO. GAMMA SCINT. COUNTER

    K Number: K800388 · Decision Mar 12, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    62
    Applicant Total
    24
    Review Days
    16

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    Basic Information

    Device Name
    NML 5000 AUTO. GAMMA SCINT. COUNTER
    K Number
    K800388
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.2320
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Nuclear Medical Laboratories, Inc.
    Date Received
    February 25, 1980
    Decision Date
    March 12, 1980
    Product Code
    JJJ
    Advisory Committee
    Clinical Chemistry
    Review Advisory Committee
    TX
    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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