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

    SCEPTOR DATA MANAGEMENT CENTER SOFTWARE

    K Number: K891577 · Decision Jun 2, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    23
    Registration Numbers
    23
    Same Product Code
    288
    Applicant Total
    632
    Review Days
    74

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    Basic Information

    Device Name
    SCEPTOR DATA MANAGEMENT CENTER SOFTWARE
    K Number
    K891577
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.1645
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Bd Becton Dickinson Vacutainer Systems Preanalytic
    Date Received
    March 20, 1989
    Decision Date
    June 2, 1989
    Product Code
    LON
    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
    LON System, Test, Automated, Antimicrobial Susceptibility, Short Incubation

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