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

    API GERM TUBE

    K Number: K812862 · Decision Oct 26, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    28
    Registration Numbers
    28
    Same Product Code
    243
    Applicant Total
    5
    Review Days
    13

    Basic Information

    Device Name
    API GERM TUBE
    K Number
    K812862
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.2660
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    ANALYTAB PRODUCTS, INC.
    Date Received
    October 13, 1981
    Decision Date
    October 26, 1981
    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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