BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇮🇪 Ireland

    UNI-GOLD STREP A TEST KIT

    K Number: K011709 · Decision Nov 8, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    19
    Registration Numbers
    19
    Same Product Code
    104
    Applicant Total
    5
    Review Days
    157

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    Basic Information

    Device Name
    UNI-GOLD STREP A TEST KIT
    K Number
    K011709
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.3740
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Trinity Biotech, Plc
    Date Received
    June 4, 2001
    Decision Date
    November 8, 2001
    Product Code
    GTZ
    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
    GTZ Antisera, All Groups, Streptococcus Spp.

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