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

    MUELLER HINTON AGAR W/OXACILLIN

    K Number: K941985 · Decision Aug 24, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    10
    Registration Numbers
    10
    Same Product Code
    73
    Applicant Total
    24
    Review Days
    121

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    Basic Information

    Device Name
    MUELLER HINTON AGAR W/OXACILLIN
    K Number
    K941985
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.1700
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Carr-Scarborough Microbiologicals, Inc.
    Date Received
    April 25, 1994
    Decision Date
    August 24, 1994
    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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    K863216 NEIS NZY
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