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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
    Why did this record match?
    Applicant Name (Manufacturer) :

    MUREX BIOTECH LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    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
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