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    K Number
    K053257
    Device Name
    PARA-PRO FC50
    Manufacturer
    ALPHA-TEC SYSTEMS, INC.
    Date Cleared
    2006-05-12

    (171 days)

    Product Code
    LKS
    Regulation Number
    866.2900
    Why did this record match?
    Applicant Name (Manufacturer) :

    ALPHA-TEC SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Para-Pro™ fc50 is a unique, patent pending device for the separation of fecal debris from the appropriate preserved specimen (10% buffered formalin; SAF sodium acetate acetic acid formaldehyde; and Proto-fix™ CLR) for the concentration of eggs, larvae, protozoa and juvenile nematodes associated with intestinal infections.
    Device Description
    Para-Pro™ fc50 is a unique, patent pending device for the separation of fecal debris from the appropriate preserved specimen (10% buffered formalin; SAF sodium acetate acetic acid formaldehyde; and Proto-fix™ CLR) for the concentration of eggs, larvae, protozoa and juvenile nematodes associated with intestinal infections.
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