BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇬🇧 United Kingdom

    WELLCOLEX E.COLI O157:H7

    K Number: K971663 · Decision Dec 30, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    10
    Registration Numbers
    10
    Same Product Code
    13
    Applicant Total
    1
    Review Days
    238

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    Basic Information

    Device Name
    WELLCOLEX E.COLI O157:H7
    K Number
    K971663
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.3255
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Murex Biotech , Ltd.
    Date Received
    May 6, 1997
    Decision Date
    December 30, 1997
    Product Code
    GMZ
    Advisory Committee
    Microbiology
    Review Advisory Committee
    MI
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    GMZ Antigens, All Types, Escherichia Coli

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