BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    BACTO-HATTS

    K Number: K791897 · Decision Nov 13, 1979
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    8
    Applicant Total
    121
    Review Days
    49

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    Basic Information

    Device Name
    BACTO-HATTS
    K Number
    K791897
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3830
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Difco Laboratories, Inc.
    Date Received
    September 25, 1979
    Decision Date
    November 13, 1979
    Product Code
    GMT
    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
    GMT Antigens, Ha, Treponema Pallidum

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