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

    API UNISCEPT KB

    K Number: K895796 · Decision Nov 13, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    10
    Registration Numbers
    10
    Same Product Code
    433
    Applicant Total
    57
    Review Days
    46

    Basic Information

    Device Name
    API UNISCEPT KB
    K Number
    K895796
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.1640
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    ANALYTICAL PRODUCTS, INC.
    Date Received
    September 28, 1989
    Decision Date
    November 13, 1989
    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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