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

    INDOLE SPOT TEST KIT 270-25

    K Number: K843316 · Decision Sep 11, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    27
    Registration Numbers
    27
    Same Product Code
    243
    Applicant Total
    7
    Review Days
    18

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    Basic Information

    Device Name
    INDOLE SPOT TEST KIT 270-25
    K Number
    K843316
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.2660
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Applied Polytechnology, Inc.
    Date Received
    August 24, 1984
    Decision Date
    September 11, 1984
    Product Code
    JTO
    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
    JTO Discs, Strips And Reagents, Microorganism Differentiation

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