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

    GENERAL PURPOSE CENTRIFUGE

    K Number: K864974 · Decision Jan 9, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    163
    Registration Numbers
    163
    Same Product Code
    37
    Applicant Total
    7
    Review Days
    21

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    Basic Information

    Device Name
    GENERAL PURPOSE CENTRIFUGE
    K Number
    K864974
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.2050
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Norfolk Scientific, Inc.
    Date Received
    December 19, 1986
    Decision Date
    January 9, 1987
    Product Code
    JQC
    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
    JQC Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use

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