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

    DRIED GRAM NEGATIVE MIC/COMBO PANELS

    K Number: K020037 · Decision Mar 22, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    10
    Registration Numbers
    10
    Same Product Code
    433
    Applicant Total
    40
    Review Days
    77

    Basic Information

    Device Name
    DRIED GRAM NEGATIVE MIC/COMBO PANELS
    K Number
    K020037
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.1640
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    DADE MICROSCAN, INC.
    Date Received
    January 4, 2002
    Decision Date
    March 22, 2002
    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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