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

    IN-VITRO DIAGNOSTIC VAGINITIS TEST KIT

    K Number: K050352 · Decision Sep 1, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    27
    Registration Numbers
    27
    Same Product Code
    243
    Applicant Total
    1
    Review Days
    202

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    Basic Information

    Device Name
    IN-VITRO DIAGNOSTIC VAGINITIS TEST KIT
    K Number
    K050352
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.2660
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Ameritek Research, LLC
    Date Received
    February 11, 2005
    Decision Date
    September 1, 2005
    Product Code
    JTO
    Advisory Committee
    Microbiology
    Review Advisory Committee
    CH
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    JTO Discs, Strips And Reagents, Microorganism Differentiation

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