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

    SYSTEM U3 FOR GENTAMICIN

    K Number: K983252 · Decision Nov 20, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    440
    Applicant Total
    3
    Review Days
    65

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    Basic Information

    Device Name
    SYSTEM U3 FOR GENTAMICIN
    K Number
    K983252
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.1640
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Ab Biodisk North America, Inc.
    Date Received
    September 16, 1998
    Decision Date
    November 20, 1998
    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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    Other Clearances by Ab Biodisk North America, Inc.

    K Number Device Name
    K950328 AMOXICILLIN/CLAVULANIC ACID 2/1
    K935519 ETEST FOR AMPICILLIN/SULBACTAM 2/1