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

    ONO/CO-TWO (TM) SYSTEMS

    K Number: K844014 · Decision Oct 31, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    82
    Applicant Total
    9
    Review Days
    19

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    Basic Information

    Device Name
    ONO/CO-TWO (TM) SYSTEMS
    K Number
    K844014
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.2410
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Micro-Bio-Logics
    Date Received
    October 12, 1984
    Decision Date
    October 31, 1984
    Product Code
    JTY
    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
    JTY Culture Media, For Isolation Of Pathogenic Neisseria

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    Other Clearances by Micro-Bio-Logics

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    K855172 KWI (TM) G-CO/TWO
    K855198 INDI KWIK (TM) CO/TWO KIT
    K852998 NEISSERIA - KWIK PLUS
    K851978 LYFO-KWIK OMI KIT
    K842129 LYFO-DISK MICROORGANISMS