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510(k) Data Aggregation

    K Number
    K083615
    Device Name
    EUROIMMUN ANTI BP 180-4X ELISA (IGG)
    Manufacturer
    EUROIMMUN US INC
    Date Cleared
    2009-03-16

    (98 days)

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

    EUROIMMUN ANTI BP 180-4X ELISA (IGG)

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

    The EUROIMMUN Anti-BP180-4X ELISA (IgG) test kit is intended for the qualitative or semiquantitative determination of IgG class autoantibodies against BP180 in human serum and plasma. It is used as an aid in the diagnosis of bullous pemphigoid (PB), in conjunction with other laboratory and clinical findings.

    Device Description

    Not Found

    AI/ML Overview

    This is a 510(k) premarket notification decision letter, not a study report. It does not contain the detailed information about acceptance criteria or specific study results to prove device performance. The letter only states that the device is "substantially equivalent" to a legally marketed predicate device.

    Therefore, I cannot provide the requested information based on the text provided. The document primarily focuses on regulatory approval and classification, not on the individual studies proving performance.

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