BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    GENZYME OSOM TRICHOMONAS RAPID TEST

    K Number: K033864 · Decision Apr 2, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    10
    Applicant Total
    27
    Review Days
    112

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    Basic Information

    Device Name
    GENZYME OSOM TRICHOMONAS RAPID TEST
    K Number
    K033864
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.2660
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Genzyme Corp.
    Date Received
    December 12, 2003
    Decision Date
    April 2, 2004
    Product Code
    JWZ
    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
    JWZ Kit, Screening, Trichomonas

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