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

    GAMMA 4000 SCINTILLATION COUNTER

    K Number: K770088 · Decision Feb 14, 1977
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    62
    Applicant Total
    281
    Review Days
    28

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    Basic Information

    Device Name
    GAMMA 4000 SCINTILLATION COUNTER
    K Number
    K770088
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.2320
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Beckman Instruments, Inc.
    Date Received
    January 17, 1977
    Decision Date
    February 14, 1977
    Product Code
    JJJ
    Advisory Committee
    Clinical Chemistry
    Review Advisory Committee
    IM
    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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