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510(k) Data Aggregation
K Number
K993098Device 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
862.1150Why 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
K971113Device Name
DMA TRIGLYCERIDES PROCEDURES
Manufacturer
DATA MEDICAL ASSOCIATES, INC.
Date Cleared
1997-05-29
(63 days)
Product Code
CDT
Regulation Number
862.1705Why 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
K961919Device Name
DMA GAMMA GLUTAMYLTRANSFERASE (GGT) PROCEDURE
Manufacturer
DATA MEDICAL ASSOCIATES, INC.
Date Cleared
1996-07-01
(45 days)
Product Code
JPZ
Regulation Number
862.1360Why 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
K955302Device Name
SERUM BICARBONATE/CARBON DIOXIDE
Manufacturer
DATA MEDICAL ASSOCIATES, INC.
Date Cleared
1996-02-29
(101 days)
Product Code
KHS
Regulation Number
862.1160Why 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
K955796Device Name
IRON CALIBRATOR & CALIBRATION VERIFICATION SET
Manufacturer
DATA MEDICAL ASSOCIATES, INC.
Date Cleared
1996-02-29
(69 days)
Product Code
JJX
Regulation Number
862.1660Why 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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