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

    MICROALBUMIN REAGENT SET AND CALIBRATORS

    K Number: K023860 · Decision Apr 28, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    12
    Registration Numbers
    12
    Same Product Code
    3
    Applicant Total
    74
    Review Days
    159

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    Basic Information

    Device Name
    MICROALBUMIN REAGENT SET AND CALIBRATORS
    K Number
    K023860
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5040
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Pointe Scientific, Inc.,
    Date Received
    November 20, 2002
    Decision Date
    April 28, 2003
    Product Code
    DDZ
    Advisory Committee
    Immunology
    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
    DDZ Albumin, Fitc, Antigen, Antiserum, Control

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