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

    ANTIMICROBIAL SUSCEPTIBILITY TEST PANEL

    K Number: K910484 · Decision Mar 11, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    440
    Applicant Total
    7
    Review Days
    33

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    Basic Information

    Device Name
    ANTIMICROBIAL SUSCEPTIBILITY TEST PANEL
    K Number
    K910484
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.1640
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Alamar
    Date Received
    February 6, 1991
    Decision Date
    March 11, 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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    Other Clearances by Alamar

    K Number Device Name
    K911391 ANTIMICROBIAL SUSCEPT. TEST PANEL (CEFTIZOXIME)
    K911389 ANTIMICROBIAL SUSCEPTIBILITY TEST PANEL (IMIPENEM)
    K911392 ANTIMICROBIAL SUSCEPTIBILITY TEST PANEL (CEFOTETAN
    K911390 ANTIMICROBIAL SUSCEPT. TEST PANEL(TRIMETHOPRIM)
    K910345 ANTIMICROBIAL CEFOPERAZONE
    K910346 ANTIMICROBIAL CEFTRIAXONE