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    K Number
    K013263
    Device Name
    FRED HUTCHINSON CANCER RESEARCH CENTER ENZYME ANTI-SR PROTEIN ANTIBODY TEST
    Manufacturer
    FRED HUTCHINSON CANCER RESEARCH CENTER
    Date Cleared
    2002-07-29

    (301 days)

    Product Code
    LKP
    Regulation Number
    866.5100
    Why did this record match?
    Applicant Name (Manufacturer) :

    FRED HUTCHINSON CANCER RESEARCH CENTER

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Fred Hutchinson Cancer Research Center Anti-SR test is an enzyme immunoassay (EIA) for the detection and semiquantitative measure of human antibodies against a type of ribonucleoproteins (RNPs) called SR Proteins. The test is intended as an aid in the diagnosis of Systemic Lupus Erythematosis (SLE) .
    Device Description
    The Fred Hutchinson Cancer Research Center Anti-SR test is an enzyme immunoassay (EIA) for the detection and semiquantitative measure of human antibodies against a type of ribonucleoproteins (RNPs) called SR Proteins.
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