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

    URINE DUO

    K Number: K851225 · Decision Aug 13, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    10
    Registration Numbers
    10
    Same Product Code
    73
    Applicant Total
    9
    Review Days
    140

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    Basic Information

    Device Name
    URINE DUO
    K Number
    K851225
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.1700
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Culture Kits, Inc.
    Date Received
    March 26, 1985
    Decision Date
    August 13, 1985
    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 Culture Kits, Inc.

    K Number Device Name
    K911846 URI-THREE(TM), MODIFICATION
    K854672 CANDI-KIT TM
    K853488 STAPH KIT
    K852582 GONI-KIT
    K852480 DERM-KIT
    K851518 MUELLER HINTON SENSITIVITY PLATE
    K850765 STREP-KIT
    K850998 URI-KIT