Search Filters

Search Results

Found 60 results

510(k) Data Aggregation

    K Number
    K070383
    Device Name
    ENZYMATIC CREATININE ASSAY (265 SERIES)
    Manufacturer
    DIAGNOSTIC CHEMICALS LTD.
    Date Cleared
    2007-06-22

    (133 days)

    Product Code
    JFY
    Regulation Number
    862.1225
    Why did this record match?
    Applicant Name (Manufacturer) :

    DIAGNOSTIC CHEMICALS LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Diagnostic Chemicals Limited Enzymatic Creatinine Assay is for the quantitative determination of creatinine in serum, plasma and urine. Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes. This device is intended for professional use and IN VITRO diagnostic use only.
    Device Description
    The Enzymatic Creatinine Assay contains an in vitro diagnostic reagent system intended for the quantitative determination of creatinine in serum, plasma and urine. Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes. Reagent is a two-part liquid in plastic bottles packaged in the appropriate box.
    Ask a Question
    K Number
    K063208
    Device Name
    MAGNESIUM ASSAY (XB), MODELS 125-12, 125-50 AND 125-S7
    Manufacturer
    DIAGNOSTIC CHEMICALS LTD.
    Date Cleared
    2007-01-19

    (88 days)

    Product Code
    JGJ, JIT
    Regulation Number
    862.1495
    Why did this record match?
    Applicant Name (Manufacturer) :

    DIAGNOSTIC CHEMICALS LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Diagnostic Chemicals Limited Magnesium Assay (XB) is for the quantitative determination of magnesium in human serum. Magnesium measurements are used in the diagnosis and treatment of hypomagnesemia (abnormally low levels of magnesium) and hypermagnesemia (abnormally high levels of magnesium). This device is intended for professional use and IN VITRO diagnostic use only. The Diagnostic Chemicals Limited Magnesium Assay (XB) Standard is used for the callbration of the Diagnostic Chemicals Limited Magnesium Assay (XB) when used for the quantitative determination of magnesium in human serum.
    Device Description
    Not Found
    Ask a Question
    K Number
    K060139
    Device Name
    CRP-ADVANCE ASSAY, MODELS 250-20, 250-25
    Manufacturer
    DIAGNOSTIC CHEMICALS LTD.
    Date Cleared
    2006-04-28

    (99 days)

    Product Code
    DCK
    Regulation Number
    866.5270
    Why did this record match?
    Applicant Name (Manufacturer) :

    DIAGNOSTIC CHEMICALS LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For the quantitative determination of C-reactive protein (CRP) in serum. For IN VITRO diagnostic use.
    Device Description
    A CRP test system is a device intended to measure CRP in serum. C-Reactive Protein (CRP) is an abnormal protein synthesized in the liver during inflammation and necrosis of cellular tissue. This method, using antihuman CRP mouse antibody coated latex to bind CRP, allows for accurate measurement over a wide range of CRP concentrations. The resulting agglutination from binding is measured spectrophotometrically and is proportional to the concentration of CRP in the sample.
    Ask a Question
    K Number
    K060140
    Device Name
    CRP-ADVANCE MULTI CALIBRATOR SET, MODEL SE-250
    Manufacturer
    DIAGNOSTIC CHEMICALS LTD.
    Date Cleared
    2006-04-24

    (95 days)

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

    DIAGNOSTIC CHEMICALS LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For the IN VITRO diagnostic use as calibrators for the DCL CRP-ADVANCE Assay for the quantitation of C-reactive protein in serum.
    Device Description
    The CRP-ADVANCE Multi-Calibrator Set, Cat. No. SE-250 are C-reactive protein standards containing known quantities of human c-reactive protein. These calibrators are to be use with the DCL CRP-ADVANCF Assay.
    Ask a Question
    K Number
    K051757
    Device Name
    CALCIUM ADVANCE ASSAY, MODEL 145-20, 145-25, 145-20-91
    Manufacturer
    DIAGNOSTIC CHEMICALS LTD.
    Date Cleared
    2005-11-10

    (134 days)

    Product Code
    CJY
    Regulation Number
    862.1145
    Why did this record match?
    Applicant Name (Manufacturer) :

    DIAGNOSTIC CHEMICALS LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For the quantitative determination of Total Calcium in serum, plasma (Lithium Heparin) and urine. For IN VITRO diagnostic use. Identification. A calcium test system is a device intended to measure total calcium in serum, plasma (Lithium Heparin) and urine. Calcium measurements are used in the diagnosis and treatment of hypercalcemia as a result from hyperparathyroidism, hypervitaminosisD, multiple myeloma and some neoplastic diseases of the bones. It is also used in the diagnosis and treatment of hypocalcemia as a result from hypoparathyroidism, steatorreah, nephritis and pancreatitis
    Device Description
    Not Found
    Ask a Question
    K Number
    K051191
    Device Name
    DCL MICROALBUMIN ASSAY, MODEL 252-20
    Manufacturer
    DIAGNOSTIC CHEMICALS LTD.
    Date Cleared
    2005-07-05

    (56 days)

    Product Code
    DCF
    Regulation Number
    866.5040
    Why did this record match?
    Applicant Name (Manufacturer) :

    DIAGNOSTIC CHEMICALS LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For the quantitative determination of low levels of albumin in urine. For IN VITRO diagnostic use.
    Device Description
    The DCL Microalbumin Assay uses an immunoturbidimetric format which provides the sensitivity required for accurate determination of urinary microalbumin.
    Ask a Question
    K Number
    K042330
    Device Name
    ACETAMINOPHEN-SL ASSAY
    Manufacturer
    DIAGNOSTIC CHEMICALS LTD.
    Date Cleared
    2005-01-07

    (133 days)

    Product Code
    LDP
    Regulation Number
    862.3030
    Why did this record match?
    Applicant Name (Manufacturer) :

    DIAGNOSTIC CHEMICALS LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Diagnostic Chemicals Limited's Acetaminophen-SL Assay is an in vitro diagnostic device intended to measure acetaminophen levels in human serum or plasma (Lithium heparin). Such measurements are used in the diagnosis of acetaminophen toxicity and overdose. This assay consists of two reagents and a calibrator.
    Device Description
    This assay consists of two reagents and a calibrator.
    Ask a Question
    K Number
    K042329
    Device Name
    SALICYLATE-SL ASSAY
    Manufacturer
    DIAGNOSTIC CHEMICALS LTD.
    Date Cleared
    2004-12-27

    (122 days)

    Product Code
    DKJ
    Regulation Number
    862.3830
    Why did this record match?
    Applicant Name (Manufacturer) :

    DIAGNOSTIC CHEMICALS LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Diagnostic Chemicals Limited's Salicylate method is an in vitro diagnostic device intended to measure salicylate levels in human serum or plasma (Lithium heparin). intended to modellio balleyfato to the diagnosis of salicylate toxicity and overdose.
    Device Description
    Not Found
    Ask a Question
    K Number
    K042362
    Device Name
    MODIFICATION TO CARBON DIOXIDE-L3K ASSAY, CAT. NOS. 299-30, 299-17, 299-50, 299-80 AND 299-12
    Manufacturer
    DIAGNOSTIC CHEMICALS LTD.
    Date Cleared
    2004-12-27

    (118 days)

    Product Code
    KHS
    Regulation Number
    862.1160
    Why did this record match?
    Applicant Name (Manufacturer) :

    DIAGNOSTIC CHEMICALS LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For the quantitative determination of carbon dioxide in serum and plasma. For IN VITRO diagnostic use.
    Device Description
    The DCL Carbon Dioxide L3K® assay is an enzymatic procedure, employing phosphoenolpyruvate carboxylase (PEPC) (2) and a stabilized NADH analog (3), which is easy to use and applicable to routine laboratory instrumentation.
    Ask a Question
    K Number
    K041926
    Device Name
    HDL/LDL-ADVANCE CALIBRATOR, CAT. NO. SE-278
    Manufacturer
    DIAGNOSTIC CHEMICALS LTD.
    Date Cleared
    2004-11-23

    (127 days)

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

    DIAGNOSTIC CHEMICALS LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For the quantitative determination of low and density lipoprotein fractions of cholesterol in serum. For IN VITRO diagnostic use. HDL/LDL-Advance Calibrator is used to calibrate HDL Cholesterol and LDL Cholesterol Assays in serum. HDL is high density lipoprotein and LDL is a low density lipoprotein.
    Device Description
    Not Found
    Ask a Question

    Page 1 of 6