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510(k) Data Aggregation

    K Number
    K972156
    Device Name
    QUIX RAPID E. COLI O157 STRIP TEST
    Manufacturer
    GUARDIAN SCIENTIFIC, CORP.
    Date Cleared
    1997-10-16

    (129 days)

    Product Code
    GMZ
    Regulation Number
    866.3255
    Why did this record match?
    Applicant Name (Manufacturer) :

    GUARDIAN SCIENTIFIC, CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Quix™ Rapid E. coli 0157 Strip Test is an immunochromatographic assay for the qualitative detection of E. coli O157 in human feces. The test is designed to be used as an aid to the diagnosis of diarrhea caused by E. coli 0157 and as an adjunct to culture methodology.
    Device Description
    The Quix™ Rapid E. coli 0157 Strip Test is an immunochromatographic assay.
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    K Number
    K954994
    Device Name
    TRUST
    Manufacturer
    GUARDIAN SCIENTIFIC, CORP.
    Date Cleared
    1996-10-18

    (353 days)

    Product Code
    GMQ
    Regulation Number
    866.3820
    Why did this record match?
    Applicant Name (Manufacturer) :

    GUARDIAN SCIENTIFIC, CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K954995
    Device Name
    QUIX RAPID CHOLERA STRIP TEST
    Manufacturer
    GUARDIAN SCIENTIFIC, CORP.
    Date Cleared
    1996-08-15

    (289 days)

    Product Code
    GSQ
    Regulation Number
    866.3930
    Why did this record match?
    Applicant Name (Manufacturer) :

    GUARDIAN SCIENTIFIC, CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question

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