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510(k) Data Aggregation

    K Number
    K062932
    Device Name
    AHLSTROM GRADE 226 SPECIMEN COLLECTION PAPER
    Manufacturer
    AHLSTROM MOUNT HOLLY SPRINGS LLC
    Date Cleared
    2007-10-19

    (386 days)

    Product Code
    JKA, PJC
    Regulation Number
    862.1675
    Why did this record match?
    Applicant Name (Manufacturer) :

    AHLSTROM MOUNT HOLLY SPRINGS LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Ahlstrom 226 specimen collection paper is intended to be used as a medium to collect and transport blood specimen spots to a laboratory. The 226 paper will be in the format of a printed card that may be incorporated along with a tear-apart form for demographic information.
    Device Description
    Ahlstrom 226 specimen collection paper is designed to provide a uniform surface for the collection of blood spots. A drop of blood is applied to the filter paper and allowed to soak through the paper. The sample is then air dried and sent to a laboratory for further analysis. This specimen collection paper is made from 100 % pure cotton linters with no wetstrength additives added and conforms to the Recognized Consensus Standard NCCLS LA4-A3. This device has 4 crucial performance characteristics that can be performed with lysed or intact red blood cells: blood absorption time, blood spot diameter, serum absorption volume, and homogeneity.
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