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510(k) Data Aggregation

    K Number
    K981436
    Device Name
    DOCUMENT AMMONIA/ETHANOL/LACTATE CALIBRATOR, PN: M-109
    Manufacturer
    CASCO STANDARDS
    Date Cleared
    1998-04-24

    (10 days)

    Product Code
    JIX
    Regulation Number
    862.1150
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    Applicant Name (Manufacturer) :

    CASCO STANDARDS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This product is intended for in vitro diagnostic for the quantitative calibration of automated, semi-automated, or manual clinical chemistry systems for the measurement of ammonia, ethanol and lactate. Each lot of DOCUMENT" Ammonia, Ethanol, Lactate Calibrator has lot specific calibration set point values for the various analytical systems on which is was assayed. This material is not intended for use on those clinical chemistry systems employing reflectance spectroscopy.
    Device Description
    Not Found
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    K Number
    K972904
    Device Name
    DOCUMENT MOLECULAR PATHOLOGY CHLAMYDIA TRACHOMATIS CONTROL
    Manufacturer
    CASCO STANDARDS
    Date Cleared
    1998-02-20

    (198 days)

    Product Code
    JJY
    Regulation Number
    862.1660
    Why did this record match?
    Applicant Name (Manufacturer) :

    CASCO STANDARDS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This product is intended for use as an unassayed control material on the Abbott LCx Probe System with the Abbott Chlamydia Amplification Kit in the qualitative determination of Chlamydia trachomatis. This product is intended to serve as an unassayed control material to monitor the analytical precision of the LCR amplification system incorporated in the Abbott LCx Probe System used in conjunction with the Abbott Chlamydia Amplification Kit. Response ratios (S/CO) have been set at appropriate positive (+) and negative (-) levels. This product is intended for in vitro use only.
    Device Description
    The DOCUMENT MOLECULAR PATHOLOGY CHLAMYDIA TRACHOMATIS Control is composed of plastic screw cap bottles, 2 mL each, containing two (2) levels of control, positive and negative, for Chlamydia trachomatis in a stabilized biological matrix. The formulation design provides a liquid matrix that is compatible with the Abbott Chlamydia Amplification Kit for assay on the LCx Probe System for the direct, qualitative determination of Chlamydia trachomatis.
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    K Number
    K962629
    Device Name
    DOCUMENT AMMONIA, ETHANOL, LACTATE CALIBRATOR
    Manufacturer
    CASCO STANDARDS
    Date Cleared
    1996-09-13

    (70 days)

    Product Code
    JIX
    Regulation Number
    862.1150
    Why did this record match?
    Applicant Name (Manufacturer) :

    CASCO STANDARDS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    DOCUMENT Ammonia, Ethanol, Lactate Calibrator is intended for in vitro diagnostic use for the quantitative calibration of automated, semi-automated, or manual clinical chemistry systems used for the measurement of ammonia. ethanol, and lactate. DOCUMENT Ammonia. Ethanol, Lactate Calibrator is intended to provide for the quantitative calibration of automated, semi-automated, and manual clinical chemistry systems. Each lot of DOCUMENT Ammonia, Ethanol, Lactate Calibrator has lot specific calibration set point values included for the various analytical systems on which it was assayed.
    Device Description
    DOCUMENT Ammonia, Ethanol, Lactate Calibrators consist of one level of an aqueous matrix containing ammonia, ethanol. and lactate. The formulation design provides a liquid calibrator intended for use on automated. semi-automated, and manual clinical chemistry systems for the quantitative determination of ammonia (AMM), ethanol (ALC) and lactate (LAC).
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    K Number
    K961750
    Device Name
    DOCUMENT CARDIAC ASSAYED CONTROL
    Manufacturer
    CASCO STANDARDS
    Date Cleared
    1996-07-22

    (77 days)

    Product Code
    JJY
    Regulation Number
    862.1660
    Why did this record match?
    Applicant Name (Manufacturer) :

    CASCO STANDARDS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This product is intended for in vitro diagnostic use as a control product to assess the analytical performance of immunochemistry systems and clinical chemistry systems using methods for the quantitative measurement of the listed analytes. It is intended to provide the necessary control material required by inspection agencies for the evaluation of system performance. In addition, it will provide assistance when troubleshooting chemistry systems, reagent problems and calibration anomalies.
    Device Description
    DOCUMENT® CARDIAC Assayed Controls consist of three levels of a human serum matrix containing creatine kinase isoenzymes, lactate dehydrogenase isoenzymes 1 and 2, and myoglobin. The formulation design provides a liquid matrix intended for use on automated and semi-automated immunochemistry systems and clinical chemistry systems for the determination of total creatine kinase activity (CK), creatine kinase MB mass (CKMB), creatine kinase immunoinhibition (CKII), creatine kinase electrophoresis (CKELEC), total lactate dehydrogenase activity (LD), lactate de dehydrogenase electrophoresis for isoenzyme 1 and 2 (LD1; LD2), and myoqlobin (MYO).
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    K Number
    K962630
    Device Name
    DOCUMENT AMMONIA, ETHANOL, LACTATE ASSAYED CONTROL
    Manufacturer
    CASCO STANDARDS
    Date Cleared
    1996-07-22

    (17 days)

    Product Code
    JJY
    Regulation Number
    862.1660
    Why did this record match?
    Applicant Name (Manufacturer) :

    CASCO STANDARDS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This product is intended for in vitro diagnostic use as a control product to assess the analytical performance of clinical chemistry systems using methods for the quantitative measurement of ammonia, ethanol, and lactate. It is intended to provide the necessary control material required by inspection agencies for the evaluation of system performance. In addition, it will provide assistance when troubleshooting chemistry systems, reagent problems and calibration anomalies.
    Device Description
    DOCUMENT Ammonia, Ethanol, Lactate Assayed Controls consist of three levels of an aqueous matrix containing ammonia, ethanol, and lactate. The formulation design provides a liquid matrix intended for use on automated, semi-automated, and manual clinical chemistry systems for the determination of ammonia (AMM), ethanol (ALC), and lactate (LAC).
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    K Number
    K960244
    Device Name
    DOCUMENT TDM ULTRA ASSAYED CONTROL
    Manufacturer
    CASCO STANDARDS
    Date Cleared
    1996-03-22

    (66 days)

    Product Code
    DIF, DKC, LAX, LAZ, LBA
    Regulation Number
    862.3280
    Why did this record match?
    Applicant Name (Manufacturer) :

    CASCO STANDARDS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This product is intended for in vitro diagnostic use as a control product to assess the analytical performance of immunochemistry systems and clinical chemistry systems using methods for the quantitative measurement of the listed analytes. It is intended to provide the necessary control material required by inspection agencies for the evaluation of system performance. In addition, it will provide assistance when troubleshooting chemistry systems, reagent problems and calibration anomalies.
    Device Description
    DOCUMENT® TDM ULTRA Assayed Controls consist of three levels of a human serum matrix containing 25 commonly monitored analytes. The formulation design provides a liquid matrix intended for use on automated and semi-automated immunochemistry systems and clinical chemistry systems for the determination of blood acetaminophen (ACET), amikacin (AMI), carbamazepine (CARB), digoxin (DIG), disopyramide (DISO), ethanol (ETOH), ethosuximide (ETHO), gentamicin (GENT) e lidocaine (LIDO), methotrexate (METH), N-acetylprocainamide (NAPA), phenobarbital (PHENO), phenytoin (PHENY), primidone (PRIM), procainamide (PROC), quinidine (QUIN), salicylate (SAL), theophylline (THEO), thyroid-stimulating hormone (hTSH), thyroxine (T4), tobramycin (TOB), triiodothyronine (T3), T-Uptake (TU), valproic acid (VAL), and vancomycin (VANCO).
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