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

    PACE-4-AUTOMATIC RIA GAMMA-COUTER

    K Number: K802578 · Decision Dec 18, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    62
    Applicant Total
    190
    Review Days
    59

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    Basic Information

    Device Name
    PACE-4-AUTOMATIC RIA GAMMA-COUTER
    K Number
    K802578
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.2320
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Philips Medical Systems (Cleveland), Inc.
    Date Received
    October 20, 1980
    Decision Date
    December 18, 1980
    Product Code
    JJJ
    Advisory Committee
    Clinical Chemistry
    Review Advisory Committee
    RA
    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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