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

    ANITIMICROBIAL SUSCEPT. TEST PANEL AMOX./CLAVUL.

    K Number: K911555 · Decision Apr 22, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    440
    Applicant Total
    26
    Review Days
    14

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    Basic Information

    Device Name
    ANITIMICROBIAL SUSCEPT. TEST PANEL AMOX./CLAVUL.
    K Number
    K911555
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.1640
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Alamar Biosciences Laboratory, Inc.
    Date Received
    April 8, 1991
    Decision Date
    April 22, 1991
    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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