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

    MUELLER HINTON AGAR

    K Number: K132491 · Decision Jun 30, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    10
    Registration Numbers
    10
    Same Product Code
    73
    Applicant Total
    1
    Review Days
    326

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    Basic Information

    Device Name
    MUELLER HINTON AGAR
    K Number
    K132491
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.1700
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Edge Biologicals, Inc.
    Date Received
    August 8, 2013
    Decision Date
    June 30, 2014
    Product Code
    JTZ
    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
    JTZ Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/Broth

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