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510(k) Data Aggregation

    K Number
    K965024
    Device Name
    N-ASSAY TIA C1-INACTIVATOR TEST KIT
    Manufacturer
    CRESTAT DIAGNOSTICS, INC.
    Date Cleared
    1997-07-14

    (209 days)

    Product Code
    DBA
    Regulation Number
    866.5250
    Type
    Traditional
    Panel
    Immunology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The N-Assay TIA C1 Inactivator Test Kit is intended to be used for the quantification of Cl Inactivator in human plasma. Cl Inactivator is measured by immunoturbidimetric assay. Measurement of Complement I Inhibitor aids in the diagnosis of hereditary angioneurotic edema and a rare form of angioedema associated with lymphoma.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text is a letter about a medical device's regulatory approval and does not contain the information requested about acceptance criteria and a study proving the device meets those criteria. The document discusses regulatory classification, marketing authorization, and general compliance but not specific performance criteria or a related study.

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