BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇦 Canada

    MUELLER HINTON AGAR LARGE

    K Number: K864246 · Decision Mar 31, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    10
    Registration Numbers
    10
    Same Product Code
    73
    Applicant Total
    21
    Review Days
    154

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    Basic Information

    Device Name
    MUELLER HINTON AGAR LARGE
    K Number
    K864246
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.1700
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Mds Laboratories, Inc.
    Date Received
    October 28, 1986
    Decision Date
    March 31, 1987
    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 Mds Laboratories, Inc.

    K Number Device Name
    K864251 SELENITE F. BROTH
    K864255 TRYPTICASE SOY BROTH
    K864238 CHOCOLATE AGAR
    K864240 COLUMBIA BLOOD AGAR WITH 5% SHEEP BLOOD
    K864241 DNASE AGAR
    K864244 GARNERELLA VAGINALIS IDENTIFICATION KIT
    K864239 CLED AGAR WITH ANDRADES INDICATOR
    K864254 THIOGLYCOLLATE BROTH
    K864237 CARY BLAIR TRANSPORT MEDIUM
    K864249 NORMAL SALINE STERILE
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