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510(k) Data Aggregation

    K Number
    K971690
    Device Name
    IMMUNOSCAN PR3-ANCA
    Manufacturer
    EURO-DIAGNOSTICA AB
    Date Cleared
    1997-10-29

    (175 days)

    Product Code
    MOB
    Regulation Number
    866.5660
    Type
    Traditional
    Panel
    Immunology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    IMMUNOSCAN PR3-ANCA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Euro-Diagnostica Immunoscan PR3-ANCA Kit is an enzyme immunoassay (EIA) kit for the in vitro detection in human serum of the subclass of Anti-Neutrophil Cytoplasmic Antibodies (ANCA) directed against proteinase-3 to be used as an aid in the diagnosis of Wegener's granulomatosis.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter for the Euro-Diagnostica Immunoscan PR3-ANCA Kit. It does not contain detailed information about the acceptance criteria or the study that proves the device meets those criteria. Such information would typically be found in the 510(k) submission itself, not in the clearance letter.

    Therefore, I cannot provide the requested information from the provided text.

    The provided text is a regulatory clearance letter and does not contain the detailed study design or results used to establish performance or acceptance criteria.

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