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

    ANTIMICROBIAL SUSCEPTIBILITY TEST PANEL

    K Number: K922780 · Decision Aug 20, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    440
    Applicant Total
    26
    Review Days
    72

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    Basic Information

    Device Name
    ANTIMICROBIAL SUSCEPTIBILITY TEST PANEL
    K Number
    K922780
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.1640
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Alamar Biosciences Laboratory, Inc.
    Date Received
    June 9, 1992
    Decision Date
    August 20, 1992
    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 Alamar Biosciences Laboratory, Inc.

    K Number Device Name
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    K925951 READAR
    K930469 ANTIMICROBIAL SUSCEPTIBILITY TEST PANEL
    K930055 ANTIMICROBIAL SUSCEPTIBILITY TEST PANEL
    K924500 ANTIMICROBIAL SUSCEPTIBILITY TEST
    K922003 ANTIMICROBIAL SUSCETIBILITY TEST PANEL
    K922168 ANTIMICROBIAL SUSCEPTIBILITY TEST PANEL
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