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510(k) Data Aggregation

    K Number
    K961755
    Device Name
    CYTOQUANT CHLAMYDIA TRANSPORT MEDIUM
    Date Cleared
    1996-05-17

    (11 days)

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

    PROTEINS INTL., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    According to 21 CFR 866.2900, microbiological specimen collection and transport devices are specimen collecting chambers intended for medical purposes to preserve the viability or integrity of micro-organisms in specimens during storage of specimens after their collection and during their transport from the collecting area to the laboratory. The device aids in the diagnosis of disease caused by pathogenic microorganisms.
    Device Description
    The CytoQuant™ Chlamydia Transport Medium (2SP) is widely recognized as an effective medium for chlamydia transport
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    K Number
    K961756
    Device Name
    CYTOQUANT VIRAL TRANSPORT MEDIUM
    Date Cleared
    1996-05-17

    (11 days)

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

    PROTEINS INTL., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    microbiological specimen collection and transport devices are specimen collecting chambers intended for medical purposes to preserve the viability or integrity of micro-organisms in specimens during storage of specimens after their collection and during their transport from the collecting area to the laboratory. The device aids in the diagnosis of disease caused by pathogenic microorganisms.
    Device Description
    microbiological specimen collection and transport devices are specimen collecting chambers intended for medical purposes to preserve the viability or integrity of micro-organisms in specimens during storage of specimens after their collection and during their transport from the collecting area to the laboratory.
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