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

    ANTIMICROBIAL SUSCEPTIBILITY TEST PANEL MODIFICATION

    K Number: K944723 · Decision Oct 21, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    440
    Applicant Total
    5
    Review Days
    25

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    Basic Information

    Device Name
    ANTIMICROBIAL SUSCEPTIBILITY TEST PANEL MODIFICATION
    K Number
    K944723
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.1640
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Alamar Biosciences, Inc.
    Date Received
    September 26, 1994
    Decision Date
    October 21, 1994
    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, Inc.

    K Number Device Name
    K943756 MICRODILUTION DEVICE FOR DETERMINING GENTAMICIN & STRRPTOMYCIN FOR DETECTION OF HIGH LEVEL AMINOGLYCOSIDE RESISTANCE
    K933885 ALAMAR BIOSCIENCES LABORATORY, INC. ANTIMICROBIAL SUSCEPTIBILITY TEST PANEL
    K930478 READAR
    K925859 READAR/SUSCEPTIBILITY, GRAM NEGATIVE PANELS