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510(k) Data Aggregation

    K Number
    K984485
    Device Name
    MICROSTAT 2
    Manufacturer
    CHEMLINK LABORATORIES LLC.
    Date Cleared
    1999-01-13

    (27 days)

    Product Code
    LRJ
    Regulation Number
    880.6890
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    CHEMLINK LABORATORIES LLC.

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

    General purpose disinfectant used to disinfect hard, nonporous, inanimate environmental surfaces in dental, medical, hospital, and veterinary facilities.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text does not contain the detailed information needed to construct the table and answer the questions regarding acceptance criteria, study details, and performance metrics of the device "Microstat 2™".

    The document is an FDA 510(k) clearance letter from 1999, which primarily states that the device is substantially equivalent to legally marketed predicate devices for its stated indications for use (general purpose disinfectant). It confirms that the device can be marketed but does not include:

    • Specific acceptance criteria (e.g., performance thresholds).
    • Details of a study proving device performance (e.g., methodology, results, sample sizes, ground truth establishment, expert qualifications, adjudication methods).
    • Information about multi-reader multi-case (MRMC) comparative effectiveness studies or standalone algorithm performance.
    • Training set details.

    Therefore, I cannot fulfill your request with the given input.

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