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510(k) Data Aggregation

    K Number
    K961950

    Validate with FDA (Live)

    Device Name
    SAS SALMONELLA O FACTOR 15 ANTISERUM &/OR O GROUP E2 FACTOR 15 ANTISERUM
    Manufacturer
    SA SCIENTIFIC, INC.
    Date Cleared
    1996-06-18

    (29 days)

    Product Code
    GRM
    Regulation Number
    866.3550
    Type
    Traditional
    Panel
    Microbiology
    Age Range
    N/A
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    Device Description
    AI/ML Overview
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    K Number
    K961954

    Validate with FDA (Live)

    Device Name
    SAS SALMONELLA H Z35 ANTISERUM
    Manufacturer
    SA SCIENTIFIC, INC.
    Date Cleared
    1996-06-18

    (29 days)

    Product Code
    GRM
    Regulation Number
    866.3550
    Type
    Traditional
    Panel
    Microbiology
    Age Range
    N/A
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    Device Description
    AI/ML Overview
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    K Number
    K961955

    Validate with FDA (Live)

    Device Name
    SAS SALMONELLA H Z42 ANTISERUM
    Manufacturer
    SA SCIENTIFIC, INC.
    Date Cleared
    1996-06-18

    (29 days)

    Product Code
    GRM
    Regulation Number
    866.3550
    Type
    Traditional
    Panel
    Microbiology
    Age Range
    N/A
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    Device Description
    AI/ML Overview
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    K Number
    K961962

    Validate with FDA (Live)

    Device Name
    SAS SALMONELLA O GROUP V FACTOR 44 ANTISERUM
    Manufacturer
    SA SCIENTIFIC, INC.
    Date Cleared
    1996-06-18

    (29 days)

    Product Code
    GRM
    Regulation Number
    866.3550
    Type
    Traditional
    Panel
    Microbiology
    Age Range
    N/A
    Reference & Predicate Devices
    N/A
    Predicate For
    K024000
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    Device Description
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    K Number
    K961963

    Validate with FDA (Live)

    Device Name
    SAS SALMONELLA O GROUP W FACTOR 45 ANTISERUM
    Manufacturer
    SA SCIENTIFIC, INC.
    Date Cleared
    1996-06-18

    (29 days)

    Product Code
    GRM
    Regulation Number
    866.3550
    Type
    Traditional
    Panel
    Microbiology
    Age Range
    N/A
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    Device Description
    AI/ML Overview
    Ask a Question

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    K Number
    K961948

    Validate with FDA (Live)

    Device Name
    SAS SALMONELLA O FACTOR 20 ANTISERUM
    Manufacturer
    SA SCIENTIFIC, INC.
    Date Cleared
    1996-06-18

    (29 days)

    Product Code
    GRM
    Regulation Number
    866.3550
    Type
    Traditional
    Panel
    Microbiology
    Age Range
    N/A
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    Device Description
    AI/ML Overview
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    K Number
    K961952

    Validate with FDA (Live)

    Device Name
    SAS SALMONELLA O FACTOR /O GROUP A FACTOR 2 ANTISERUMS
    Manufacturer
    SA SCIENTIFIC, INC.
    Date Cleared
    1996-06-18

    (29 days)

    Product Code
    GRM
    Regulation Number
    866.3550
    Type
    Traditional
    Panel
    Microbiology
    Age Range
    N/A
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    Device Description
    AI/ML Overview
    Ask a Question

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    K Number
    K961953

    Validate with FDA (Live)

    Device Name
    SAS SALMONELA H Z24 ANTISERUM
    Manufacturer
    SA SCIENTIFIC, INC.
    Date Cleared
    1996-06-18

    (29 days)

    Product Code
    GRM
    Regulation Number
    866.3550
    Type
    Traditional
    Panel
    Microbiology
    Age Range
    N/A
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    Device Description
    AI/ML Overview
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    K Number
    K961956

    Validate with FDA (Live)

    Device Name
    SAS SALMONELLA H G,M,Q ANTISERMU
    Manufacturer
    SA SCIENTIFIC, INC.
    Date Cleared
    1996-06-18

    (29 days)

    Product Code
    GRM
    Regulation Number
    866.3550
    Type
    Traditional
    Panel
    Microbiology
    Age Range
    N/A
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    Device Description
    AI/ML Overview
    Ask a Question

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    K Number
    K961957

    Validate with FDA (Live)

    Device Name
    SAS SALMONELLA H Z4, Z32 ANTISERUM
    Manufacturer
    SA SCIENTIFIC, INC.
    Date Cleared
    1996-06-18

    (29 days)

    Product Code
    GRM
    Regulation Number
    866.3550
    Type
    Traditional
    Panel
    Microbiology
    Age Range
    N/A
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    Device Description
    AI/ML Overview
    Ask a Question

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