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510(k) Data Aggregation

    K Number
    K983280
    Device Name
    VANCOMYCIN EIA ASSAY
    Manufacturer
    DIAGNOSTIC REAGENTS, INC.
    Date Cleared
    1998-11-06

    (49 days)

    Product Code
    LEH
    Regulation Number
    862.3950
    Type
    Traditional
    Panel
    Toxicology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    VANCOMYCIN EIA ASSAY

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

    The Vancomycin Enzyme Immunoassay is intended for in vitro diagnostic use for quantitative determination of vancomycin in human serum or plasma.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) premarket notification approval letter for the Vancomycin Enzyme Immunoassay. It does not contain information about acceptance criteria, study designs, sample sizes, expert qualifications, or ground truth establishment. This type of information is typically found in the 510(k) submission document itself, not in the FDA's approval letter.

    Therefore, I cannot fulfill your request with the given input. The document is solely an approval stating that the device is substantially equivalent to legally marketed predicate devices and can be marketed.

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