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

    MUELLER HINTON SENSITIVITY PLATE

    K Number: K851518 · Decision Apr 29, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    10
    Registration Numbers
    10
    Same Product Code
    73
    Applicant Total
    9
    Review Days
    14

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    Basic Information

    Device Name
    MUELLER HINTON SENSITIVITY PLATE
    K Number
    K851518
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.1700
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Culture Kits, Inc.
    Date Received
    April 15, 1985
    Decision Date
    April 29, 1985
    Product Code
    JTZ
    Advisory Committee
    Microbiology
    Review Advisory Committee
    IM
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    JTZ Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/Broth

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