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

    MUELLER HINTON AGAR

    K Number: K800987 · Decision Jun 2, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    10
    Registration Numbers
    10
    Same Product Code
    73
    Applicant Total
    11
    Review Days
    40

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    Basic Information

    Device Name
    MUELLER HINTON AGAR
    K Number
    K800987
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.1700
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Quality Assurance Laboratory, Inc.
    Date Received
    April 23, 1980
    Decision Date
    June 2, 1980
    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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    Other Clearances by Quality Assurance Laboratory, Inc.

    K Number Device Name
    K800986 TRYPTICASE SOY AGAR W5% SHEEP BLOOD
    K800981 CHOCOLATE AGAR W/ENRICHMENTS
    K800978 XYLOSE LYSINE DESOXYCHOLATE AGAR
    K800985 THIOGLYCOLLATE MED. W/O INDICATOR
    K800977 THAYER-MARTIN AGAR
    K800983 MACCONKEY AGAR
    K800979 MUELLER HINTIN AGAR W/5% SHEEP BLOOD
    K800984 EOSIN METHYLENE BLUE AGAR, LEVINE
    K800980 HEXTOEN ENTERIC AGAR
    K800982 SALMONELLA SHIGELLA AGAR
    Search all 11 clearances from Quality Assurance Laboratory, Inc. →