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

    REFERENCE CHECK, CATALOG NUMBER-RCN-10

    K Number: K013708 · Decision Dec 10, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    15
    Registration Numbers
    15
    Same Product Code
    19
    Applicant Total
    10
    Review Days
    32

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    Basic Information

    Device Name
    REFERENCE CHECK, CATALOG NUMBER-RCN-10
    K Number
    K013708
    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
    November 8, 2001
    Decision Date
    December 10, 2001
    Product Code
    GIZ
    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
    GIZ Plasma, Control, Normal

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