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510(k) Data Aggregation

    K Number
    K981030
    Device Name
    BINDAZYME ANTI-MPO ENZYME IMMUNOASSAY KIT
    Manufacturer
    THE BINDING SITE, LTD.
    Date Cleared
    1998-07-20

    (123 days)

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

    BINDAZYME ANTI-MPO ENZYME IMMUNOASSAY KIT

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

    This assay is intended for the in-vitro Measurement of Spectric rige a aid in the diagnosis of certain types (Mro) present in Serum, as an ara in che and can conserulonephritis of aucolimatic vasourcess, in: ading onjunction with other clinical findings.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text does not contain the information needed to answer your request about acceptance criteria and a study proving a device meets them. The document is a 510(k) clearance letter from the FDA for a device called "Bindazyme Anti-MPO Enzyme Immunoassay Kit". It states that the device is substantially equivalent to a predicate device and can be marketed. It does not include details about specific acceptance criteria or an efficacy study.

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