LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K984017
    Device Name
    ALLISON MEDICAL INSULIN SYRINGE (AMIS)
    Manufacturer
    ALLISON MEDICAL, INC.
    Date Cleared
    1999-03-04

    (112 days)

    Product Code
    FMF
    Regulation Number
    880.5860
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Insulin syringes are intended for the injection of insulin.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) clearance letter from the FDA for an "Allison Medical Insulin Syringe (AMIS)". This document is not a study report or a device performance evaluation. It is a regulatory letter indicating that the FDA has found the device to be "substantially equivalent" to predicate devices already on the market, thus allowing it to be marketed.

    Therefore, the document does not contain the information requested in the prompt regarding acceptance criteria, study details, sample sizes, ground truth establishment, or expert qualifications.

    To answer your prompt, I would need a different type of document, such as a clinical study report, a scientific publication detailing performance evaluation, or a submission document that includes the technical specifications and testing results for the device.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1