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510(k) Data Aggregation

    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?
    Product Code :

    LKS

    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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    K Number
    K021420
    Device Name
    PARACON II/FECAL CONCENTRATOR II
    Manufacturer
    PARA SCIENTIFIC CO.
    Date Cleared
    2002-06-04

    (32 days)

    Product Code
    LKS
    Regulation Number
    866.2900
    Why did this record match?
    Product Code :

    LKS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    ParaCon II / Fecal Concentrator II is a filtration device that is intended for use in the separation of intestinal parasites from: fecal debris in preserved fecal specimens. Fecal specimens that have been preserved in preservatives such as formalin, sodium acetate-acetic acid-formalin, merthiolate-formalin, or modified polyvinyl alcohol, and which are contained in 30 ml transport vials, may be mated to the ParaCon II / Fecal Concentrator II filtration device and inverted in order to separate fecal debris from the specimen. The filtered specimen may then be concentrated by centrifugation, and observed microscopically.
    Device Description
    ParaCon II / Fecal Concentrator II is a filtration device.
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    K Number
    K980077
    Device Name
    PARA-PAK SPINCON
    Manufacturer
    MERIDIAN DIAGNOSTICS, INC.
    Date Cleared
    1998-04-02

    (84 days)

    Product Code
    LKS
    Regulation Number
    866.2900
    Why did this record match?
    Product Code :

    LKS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Para-Pak SPINCON is for the concentration of eggs, larvae, and protozoa from preserved fecal specimens. Specimens preserved in 10% Formalin, Sodium Acetate Formalin (SAF), and ECOFIX may be used with the system.
    Device Description
    Para-Pak SPINCON involves passing a surfactant treated, preserved stool specimen through a preliminary screen by gravity flow. The surfactant helps to break down fecal aggregates, thus freeing parasites. The specimen is then forced by centrifugation through a series of two screens with successively smaller mesh. The series of screens, not present in other devices, trap stool debris, yet allow even the larger parasites to pass through. This second filtration step eliminates the need for organic solvent extraction of the stool specimen. The resulting pellet may be examined for the presence of parasites by standard wet mount procedures. SPINCON Devices: 200/500 SPINCON Caps: 200/500 SPINCON Preliminary Funnel Screens: 200/500 Para-Pak Surfactant: 33ml
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