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510(k) Data Aggregation

    K Number
    K981783
    Device Name
    C3 MININEPH ANTISERUM
    Manufacturer
    THE BINDING SITE, LTD.
    Date Cleared
    1999-12-20

    (579 days)

    Product Code
    CZW
    Regulation Number
    866.5240
    Type
    Traditional
    Panel
    Immunology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    This assay is designed for the in vitro measurement of human C3 on an accepted analyzer as an aid in the diagnosis of abnormal C3 metabolism.

    Device Description

    Not Found

    AI/ML Overview

    This is an FDA Premarket Notification (510(k)) K981783 for C3 Minineph Antiserum. The document is a clearance letter and does not contain details about acceptance criteria or specific study designs to prove device performance. The letter states that the device is substantially equivalent to legally marketed predicate devices.

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

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