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

    SCEPTOR- NEW ANTIMICROBIAL AGENT: NORFLOXACIN

    K Number: K881846 · Decision Jul 8, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    10
    Registration Numbers
    10
    Same Product Code
    433
    Applicant Total
    632
    Review Days
    67

    Basic Information

    Device Name
    SCEPTOR- NEW ANTIMICROBIAL AGENT: NORFLOXACIN
    K Number
    K881846
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.1640
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
    Date Received
    May 2, 1988
    Decision Date
    July 8, 1988
    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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