BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    TREND GIARDIA DIRECT DETECTION RS TEST SYSTEM

    K Number: K953284 · Decision Oct 6, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    18
    Registration Numbers
    18
    Same Product Code
    26
    Applicant Total
    6
    Review Days
    85

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    Basic Information

    Device Name
    TREND GIARDIA DIRECT DETECTION RS TEST SYSTEM
    K Number
    K953284
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3220
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Trend Scientific, Inc.
    Date Received
    July 13, 1995
    Decision Date
    October 6, 1995
    Product Code
    MHI
    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
    MHI Giardia Spp.

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