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

    METRONIDAZOLE DISCS

    K Number: K801805 · Decision Feb 10, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    440
    Applicant Total
    56
    Review Days
    196

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    Basic Information

    Device Name
    METRONIDAZOLE DISCS
    K Number
    K801805
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.1640
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    G.D. Searle and Co.
    Date Received
    July 29, 1980
    Decision Date
    February 10, 1981
    Product Code
    JWY
    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
    JWY Manual Antimicrobial Susceptibility Test Systems

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