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510(k) Data Aggregation

    K Number
    K981786
    Device Name
    IGA MININEPH ANTISERUM
    Manufacturer
    THE BINDING SITE, LTD.
    Date Cleared
    1999-11-24

    (553 days)

    Product Code
    CFQ
    Regulation Number
    866.5510
    Type
    Traditional
    Panel
    Immunology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    IGA MININEPH ANTISERUM

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

    This assay is designed for the in vitro measurement of human IgA in serum using the MININEPH analyzer.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) clearance letter from the FDA for a device named "Minineph IgA antiserum." This document indicates that the device is a reclassified in vitro diagnostic device and does not contain information about the acceptance criteria, study details, or performance metrics in the context of an AI/ML powered device. The letter is a clearance notification and not a study report. Therefore, I cannot extract the requested information from this document.

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