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510(k) Data Aggregation

    K Number
    K023239
    Device Name
    AIA-PACK CA 19-9
    Manufacturer
    TOSOH CORP.
    Date Cleared
    2002-12-23

    (87 days)

    Product Code
    NIG
    Regulation Number
    866.6010
    Why did this record match?
    Applicant Name (Manufacturer) :

    TOSOH CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    AIA-PACK™ CA 19-9 is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of CA 19-9 tumor associated antigen in human serum on TOSOH AIA Nex•IA and AIA-600II Immunoassay analyzers. Serial testing using the AIA-PACK™ CA 19-9 is to be used as an aid in monitoring the disease status in patients who have been diagnosed with pancreatic cancer and who show measurable CA 19-9 results over the course of their disease. Results of CA 19-9 testing should be used in conjunction with other clinical methods that are standard of care for monitoring disease status in these patients.
    Device Description
    AIA-PACK™ CA 19-9 is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of CA 19-9 tumor associated antigen in human serum on TOSOH AIA Nex•IA and AIA-600II Immunoassay analyzers.
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    K Number
    K023240
    Device Name
    ST AIA-PACK CA 19-9
    Manufacturer
    TOSOH CORP.
    Date Cleared
    2002-12-23

    (87 days)

    Product Code
    NIG
    Regulation Number
    866.6010
    Why did this record match?
    Applicant Name (Manufacturer) :

    TOSOH CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    ST AIA-PACK™ CA 19-9 is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of CA 19-9 tumor associated antigen in human serum on TOSOH AIA Nex•IA and AIA-600II Immunoassay analyzers. Serial testing using the ST AIA-PACK™ CA 19-9 is to be used as an aid in monitoring the disease status in patients who have been diagnosed with pancreatic cancer and who show measurable CA 19-9 results over the course of their disease. Results of CA 19-9 testing should be used in conjunction with other clinical methods that are standard of care for monitoring disease status in these patients.
    Device Description
    Not Found
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