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

    MUELLER HINTON AGAR W/4%NACL AND OXACILLIN

    K Number: K863821 · Decision Oct 9, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    10
    Registration Numbers
    10
    Same Product Code
    73
    Applicant Total
    67
    Review Days
    9

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    Basic Information

    Device Name
    MUELLER HINTON AGAR W/4%NACL AND OXACILLIN
    K Number
    K863821
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.1700
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Gibco Laboratories Life Technologies, Inc.
    Date Received
    September 30, 1986
    Decision Date
    October 9, 1986
    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 Gibco Laboratories Life Technologies, Inc.

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    K863289 CDC ANAEROBIC AGAR W/SHEEP BLOOD, KANA-&VANCOMYCIN
    K862425 MACCONKEY AGAR W/MUG, DRI-FORM AND PRE-FORM
    K861058 SENSITITRE AUTO ID PLATE, AP70
    K861734 REGAN-LOWE AGAR
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