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

    XENOSTRIP-TV TRICHOMONAS CASSETTE TEST, MODEL C1383.01

    K Number: K020595 · Decision Feb 20, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    10
    Applicant Total
    1
    Review Days
    363

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    Basic Information

    Device Name
    XENOSTRIP-TV TRICHOMONAS CASSETTE TEST, MODEL C1383.01
    K Number
    K020595
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.2660
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Xenotope Diagnostics, Inc.
    Date Received
    February 22, 2002
    Decision Date
    February 20, 2003
    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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