BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    STATSPIN MINI-PLASMA

    K Number: K893613 · Decision Aug 28, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    218
    Registration Numbers
    218
    Same Product Code
    235
    Applicant Total
    4
    Review Days
    110

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    Basic Information

    Device Name
    STATSPIN MINI-PLASMA
    K Number
    K893613
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    862.1675
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Statspin Technologies
    Date Received
    May 10, 1989
    Decision Date
    August 28, 1989
    Product Code
    JKA
    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
    JKA Tubes, Vials, Systems, Serum Separators, Blood Collection

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    Other Clearances by Statspin Technologies

    K Number Device Name
    K903698 STATSPIN MICRO-HEMATOCRIT READER FOR 75MM TUBES
    K896206 STATSPIN STATSAMPLER
    K884807 LIPOCLEAR LIPEMIA CLEARING REAGENT