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

    REAADS IGG ANTI-PROTHROMBIN SEMI-QUANTITATIVE TEST KIT

    K Number: K001352 · Decision Apr 9, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    15
    Applicant Total
    23
    Review Days
    346

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    Basic Information

    Device Name
    REAADS IGG ANTI-PROTHROMBIN SEMI-QUANTITATIVE TEST KIT
    K Number
    K001352
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.5820
    Medical Specialty
    Immunology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Corgenix, Inc.
    Date Received
    April 28, 2000
    Decision Date
    April 9, 2001
    Product Code
    DHC
    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
    DHC System, Test, Systemic Lupus Erythematosus

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