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510(k) Data Aggregation

    K Number
    K993098
    Device Name
    HDL-C/LDL-C CALIBRATOR, MODEL 1913-003
    Manufacturer
    DATA MEDICAL ASSOCIATES, INC.
    Date Cleared
    1999-10-08

    (22 days)

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

    DATA MEDICAL ASSOCIATES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For the calibration of in-vitro diagnostic methods for the direct quantitative determination of HDL Cholesterol and LDL Cholesterol in serum.
    Device Description
    DMA's HDL Cholesterol and LDL Cholesterol calibrator is intended for the calibration of in-vitro diagnostic methods for the direct quantitative determination of HDLC and LDLC in serum.
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    K Number
    K971113
    Device Name
    DMA TRIGLYCERIDES PROCEDURES
    Manufacturer
    DATA MEDICAL ASSOCIATES, INC.
    Date Cleared
    1997-05-29

    (63 days)

    Product Code
    CDT
    Regulation Number
    862.1705
    Why did this record match?
    Applicant Name (Manufacturer) :

    DATA MEDICAL ASSOCIATES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For the quantitative determination of Triglycerides in serum and plasma. Triglyceride measurements are used in the diagnosis and treatment of patients with diabetes mellitus, nephrosis, liver obstruction, other diseases involving lipid merabolism, or various endocrine disorders. Elevated serum triglyceride levels are seen in primary disorders of lipid metabolism or hyperlipoproteinemia secondary to known diseases. Furthermore, in conjunction with high-density lipoprotein and total serum cholesterol, a triglyceride determination provides valuable information for the assessment of coronary heart disease risk. The clinical significance and management of hyperlipoproteinemia depends on the triglyceride distribution among the major serum lipoproteins.
    Device Description
    DMA's Triglyceride (GPO) Procedure is intended for in vitro diagnostic use for the quantitative determination of triglycerides in human serum or plasma. It is quite similar to many other assays which have long been used for this purpose.
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    K Number
    K961919
    Device Name
    DMA GAMMA GLUTAMYLTRANSFERASE (GGT) PROCEDURE
    Manufacturer
    DATA MEDICAL ASSOCIATES, INC.
    Date Cleared
    1996-07-01

    (45 days)

    Product Code
    JPZ
    Regulation Number
    862.1360
    Why did this record match?
    Applicant Name (Manufacturer) :

    DATA MEDICAL ASSOCIATES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For in-vitro diagnostic use. For the quantitative determination of gamma glutamyltransferase in serum.
    Device Description
    The method is based on the reaction wherein gamyl glutamyltransferase catalyzes the transfer of the glutamyl group from L-g-glutamyl-3-carboxy-4-nitroanilide to glycylglycine with the formation of g-glutamylglycylglycine and 5-amino-2-nitrobenzoate. The rate of increase of 5-amino-2-nitrobenzene, which absorbs light at 405 nM. is proportional to the gamma glutamyltransferase activity in the sample.
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    K Number
    K955302
    Device Name
    SERUM BICARBONATE/CARBON DIOXIDE
    Manufacturer
    DATA MEDICAL ASSOCIATES, INC.
    Date Cleared
    1996-02-29

    (101 days)

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

    DATA MEDICAL ASSOCIATES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K955796
    Device Name
    IRON CALIBRATOR & CALIBRATION VERIFICATION SET
    Manufacturer
    DATA MEDICAL ASSOCIATES, INC.
    Date Cleared
    1996-02-29

    (69 days)

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

    DATA MEDICAL ASSOCIATES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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