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

    HAPTOGLOBIN NEPHELOMETRIC ASSAY

    K Number: K801433 · Decision Jul 8, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    32
    Registration Numbers
    32
    Same Product Code
    17
    Applicant Total
    54
    Review Days
    20

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    Basic Information

    Device Name
    HAPTOGLOBIN NEPHELOMETRIC ASSAY
    K Number
    K801433
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5460
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Applicant
    J.T. Baker Chemical Co.
    Date Received
    June 18, 1980
    Decision Date
    July 8, 1980
    Product Code
    DAD
    Advisory Committee
    Immunology
    Review Advisory Committee
    IM
    Third Party
    N

    Classifications

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

    Product Code Device Name
    DAD Haptoglobin, Antigen, Antiserum, Control

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