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

    STAVIP 3000

    K Number: K864436 · Decision Mar 16, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    33
    Applicant Total
    24
    Review Days
    124

    Basic Information

    Device Name
    STAVIP 3000
    K Number
    K864436
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.2485
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    ROSEBURG SA
    Date Received
    November 12, 1986
    Decision Date
    March 16, 1987
    Product Code
    JJN
    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
    JJN Apparatus, Electrophoresis, For Clinical Use

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