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

    STAPHYTECT-OD

    K Number: K940557 · Decision Jul 28, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    2
    Applicant Total
    73
    Review Days
    171

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    Basic Information

    Device Name
    STAPHYTECT-OD
    K Number
    K940557
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.3700
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Unipath , Ltd.
    Date Received
    February 7, 1994
    Decision Date
    July 28, 1994
    Product Code
    LHJ
    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
    LHJ Staphylococcus Aureus Protein A Insoluble

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