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510(k) Data Aggregation

    K Number
    K972386
    Device Name
    VISTA ANTIGEN SALMONELLA O GROUP B
    Manufacturer
    LEE LABORATORIES, INC.
    Date Cleared
    1997-08-25

    (60 days)

    Product Code
    GNC
    Regulation Number
    866.3550
    Why did this record match?
    Applicant Name (Manufacturer) :

    LEE LABORATORIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Screening for and/or confirmation of certain febrile diseases by the detection of antibodies in serum
    Device Description
    Not Found
    Ask a Question
    K Number
    K972387
    Device Name
    VISTA ANTIGEN SALMONELLA O GROUP A
    Manufacturer
    LEE LABORATORIES, INC.
    Date Cleared
    1997-08-25

    (60 days)

    Product Code
    GNC
    Regulation Number
    866.3550
    Why did this record match?
    Applicant Name (Manufacturer) :

    LEE LABORATORIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Screening for and/or confirmation of certain febrile diseases by the detection of antibodies in serum
    Device Description
    Not Found
    Ask a Question
    K Number
    K972388
    Device Name
    VISTA ANTIGEN SALMONELLA O GROUP C
    Manufacturer
    LEE LABORATORIES, INC.
    Date Cleared
    1997-08-25

    (60 days)

    Product Code
    GNC
    Regulation Number
    866.3550
    Why did this record match?
    Applicant Name (Manufacturer) :

    LEE LABORATORIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Screening for and/or confirmation of certain febrile diseases by the detection of antibodies in serum
    Device Description
    Not Found
    Ask a Question
    K Number
    K972389
    Device Name
    VISTA ANTIGEN SALMONELLA H D
    Manufacturer
    LEE LABORATORIES, INC.
    Date Cleared
    1997-08-25

    (60 days)

    Product Code
    GNC
    Regulation Number
    866.3550
    Why did this record match?
    Applicant Name (Manufacturer) :

    LEE LABORATORIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Screening for and/or confirmation of certain febrile diseases by the detection of antibodies in serum
    Device Description
    Not Found
    Ask a Question
    K Number
    K972390
    Device Name
    VISTA ANTIGEN SALMONELLA H C
    Manufacturer
    LEE LABORATORIES, INC.
    Date Cleared
    1997-08-25

    (60 days)

    Product Code
    GNC
    Regulation Number
    866.3550
    Why did this record match?
    Applicant Name (Manufacturer) :

    LEE LABORATORIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Screening for and/or confirmation of certain febrile diseases by the detection of antibodies in serum
    Device Description
    Not Found
    Ask a Question
    K Number
    K972391
    Device Name
    VISTA ANTIGEN SALMONELLA H B
    Manufacturer
    LEE LABORATORIES, INC.
    Date Cleared
    1997-08-25

    (60 days)

    Product Code
    GNC
    Regulation Number
    866.3550
    Why did this record match?
    Applicant Name (Manufacturer) :

    LEE LABORATORIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Screening for and/or confirmation of certain febrile diseases by the detection of antibodies in serum
    Device Description
    Not Found
    Ask a Question
    K Number
    K972392
    Device Name
    VISTA ANTIGEN SALMONELLA H A
    Manufacturer
    LEE LABORATORIES, INC.
    Date Cleared
    1997-08-25

    (60 days)

    Product Code
    GNC
    Regulation Number
    866.3550
    Why did this record match?
    Applicant Name (Manufacturer) :

    LEE LABORATORIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Screening for and/or confirmation of certain febrile diseases by the detection of antibodies in serum
    Device Description
    Not Found
    Ask a Question
    K Number
    K972394
    Device Name
    VISTA ANTIGEN BRUCELLA ABORTUS
    Manufacturer
    LEE LABORATORIES, INC.
    Date Cleared
    1997-08-25

    (60 days)

    Product Code
    GSO
    Regulation Number
    866.3085
    Why did this record match?
    Applicant Name (Manufacturer) :

    LEE LABORATORIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Screening for and/or confirmation of certain febrile diseases by the detection of antibodies in serum
    Device Description
    Not Found
    Ask a Question
    K Number
    K972395
    Device Name
    VISTA ANTIGEN SALMONELLA O GROUP D
    Manufacturer
    LEE LABORATORIES, INC.
    Date Cleared
    1997-08-25

    (60 days)

    Product Code
    GNC
    Regulation Number
    866.3550
    Why did this record match?
    Applicant Name (Manufacturer) :

    LEE LABORATORIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Screening for and/or confirmation of certain febrile diseases by the detection of antibodies in serum
    Device Description
    Not Found
    Ask a Question
    K Number
    K972396
    Device Name
    VISTA ANTIGEN BRUCELLA MELITENSIS
    Manufacturer
    LEE LABORATORIES, INC.
    Date Cleared
    1997-08-25

    (60 days)

    Product Code
    GSO
    Regulation Number
    866.3085
    Why did this record match?
    Applicant Name (Manufacturer) :

    LEE LABORATORIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Screening for and/or confirmation of certain febrile diseases by the detection of antibodies in serum
    Device Description
    Not Found
    Ask a Question

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