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510(k) Data Aggregation

    K Number
    K000718
    Device Name
    CHROMOSTREAK
    Manufacturer
    Date Cleared
    2000-08-24

    (174 days)

    Product Code
    Regulation Number
    866.2390
    Why did this record match?
    Applicant Name (Manufacturer) :

    NOVAMED LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Device Description
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    K Number
    K974428
    Device Name
    DIPSTREAK
    Manufacturer
    Date Cleared
    1998-07-30

    (248 days)

    Product Code
    Regulation Number
    866.2360
    Why did this record match?
    Applicant Name (Manufacturer) :

    NOVAMED LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Novamed, Ltd. DipStreak Urine Culture Device is used for the isolation and enumeration of bacteria in urine. A set of plastic prongs on the end of the device are dipped into the urine sample. The drops of urine which adhere to the prongs are then streaked across two different agar surfaces (CLED agar on one side, MacConkey agar on the other). A dilution effect takes place which allows the isolation of single colonies.
    Device Description
    DipStreak comprises a plastic paddle with two types of agar attached back-to-back, housed in a closed transparent plastic tube. A ring with elongated prongs is attached to the end of the paddle so that there are prongs on each side of the slide. The ends of the prongs are dipped into the urine sample. Upon re-insertion into the plastic tube, the prongs are prevented from moving and the agar surfaces are inoculated with bacteria from the urine sample as the agar-coated paddle passes over the prongs. The result is a series of streaks of decreasing bacterial concentration which permits isolation of single colonies even when the original bacterial population of the sample was as high as 10' organisms per milliliter.
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