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510(k) Data Aggregation

    K Number
    K971663
    Device Name
    WELLCOLEX E.COLI O157:H7
    Manufacturer
    MUREX BIOTECH LTD.
    Date Cleared
    1997-12-30

    (238 days)

    Product Code
    GMZ
    Regulation Number
    866.3255
    Type
    Traditional
    Panel
    Microbiology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    MUREX BIOTECH LTD.

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

    Wellcolex E.coli 0157:H7 is a rapid latex agglutination test for the presumptive identification of Escherichia coli 0157:H7 isolates on laboratory media.

    Device Description

    Not Found

    AI/ML Overview

    The provided document is a 510(k) clearance letter from the FDA for a device called "Wellcolex E.coli 0157:H7 - ZC61". It certifies that the device is substantially equivalent to a legally marketed predicate device. However, this letter does not contain any information regarding specific acceptance criteria, study methodologies, sample sizes for training or test sets, expert qualifications, or adjudication methods.

    Therefore, I cannot extract the requested information from this document. The letter only confirms that the device has been cleared for marketing based on its substantial equivalence to a predicate device for the presumptive identification of Escherichia coli O157:H7 isolates on laboratory media.

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