BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    CULTURIA MACCONKEY-MUG/CLED SYSTEMS

    K Number: K864764 · Decision Dec 29, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    30
    Registration Numbers
    30
    Same Product Code
    284
    Applicant Total
    6
    Review Days
    24

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    Basic Information

    Device Name
    CULTURIA MACCONKEY-MUG/CLED SYSTEMS
    K Number
    K864764
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.2360
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Clinical Convenience Products, Inc.
    Date Received
    December 5, 1986
    Decision Date
    December 29, 1986
    Product Code
    JSI
    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
    JSI Culture Media, Selective And Differential

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    Other Clearances by Clinical Convenience Products, Inc.

    K Number Device Name
    K934759 CULTURIA MACCONKEY-MUG
    K870502 CULTURIA MACCONKEY-MUG/MODIFIED TSA SYSTEMS
    K800215 CULTURIA MACCONKEY/CLED #DM87
    K792579 CULTURIA MACCONKEY/COLUMBIA CNA
    K792284 CULTURIA EMB/COLUMBIA CNA W/5% SHEEP