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

    QWIKSPIN (TM)

    K Number: K860172 · Decision Feb 11, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    164
    Registration Numbers
    164
    Same Product Code
    37
    Applicant Total
    7
    Review Days
    25

    Basic Information

    Device Name
    QWIKSPIN (TM)
    K Number
    K860172
    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
    January 17, 1986
    Decision Date
    February 11, 1986
    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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