LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K993612
    Device Name
    BINDAZYME ANTI-TISSUE TRANSGLUTAMINASE IGA EIA
    Manufacturer
    THE BINDING SITE, LTD.
    Date Cleared
    1999-12-21

    (57 days)

    Product Code
    MVM
    Regulation Number
    866.5660
    Type
    Traditional
    Panel
    Immunology
    Reference & Predicate Devices
    N/A
    Predicate For
    K041002
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The in-vitro measurement of specific autoantibodies against tissue transglutaminase (tTG) present in serum as an aid in the diagnosis of Coeliac disease.

    Device Description

    BINDAZYME Anti-Tissue Transglutaminase IgA EIA Kit

    AI/ML Overview

    This document is a marketing authorization letter for a device called "BINDAZYME Anti-Tissue Transglutaminase IgA EIA". It does not contain information about acceptance criteria or a study proving device performance in the format requested. The document is a regulatory approval notice from the FDA, stating that the device is substantially equivalent to legally marketed predicate devices.

    Therefore, I cannot provide the requested information from this document.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1