BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇦 Canada

    CRYOCHECK WEAK LUPUS POSITIVE CONTROL

    K Number: K032804 · Decision Nov 3, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    18
    Registration Numbers
    18
    Same Product Code
    39
    Applicant Total
    10
    Review Days
    55

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    Basic Information

    Device Name
    CRYOCHECK WEAK LUPUS POSITIVE CONTROL
    K Number
    K032804
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    864.5425
    Medical Specialty
    Hematology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Precision Biologic
    Date Received
    September 9, 2003
    Decision Date
    November 3, 2003
    Product Code
    GGC
    Advisory Committee
    Hematology
    Review Advisory Committee
    HE
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    GGC Control, Plasma, Abnormal

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