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510(k) Data Aggregation
K Number
K070383Device Name
ENZYMATIC CREATININE ASSAY (265 SERIES)
Manufacturer
DIAGNOSTIC CHEMICALS LTD.
Date Cleared
2007-06-22
(133 days)
Product Code
JFY
Regulation Number
862.1225Why 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.
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K Number
K063208Device 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
862.1495Why 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
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K Number
K060139Device 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
866.5270Why 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.
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K Number
K060140Device 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
862.1150Why 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.
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K Number
K051757Device 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
862.1145Why 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
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K Number
K051191Device Name
DCL MICROALBUMIN ASSAY, MODEL 252-20
Manufacturer
DIAGNOSTIC CHEMICALS LTD.
Date Cleared
2005-07-05
(56 days)
Product Code
DCF
Regulation Number
866.5040Why 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.
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K Number
K042330Device Name
ACETAMINOPHEN-SL ASSAY
Manufacturer
DIAGNOSTIC CHEMICALS LTD.
Date Cleared
2005-01-07
(133 days)
Product Code
LDP
Regulation Number
862.3030Why 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.
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K Number
K042329Device Name
SALICYLATE-SL ASSAY
Manufacturer
DIAGNOSTIC CHEMICALS LTD.
Date Cleared
2004-12-27
(122 days)
Product Code
DKJ
Regulation Number
862.3830Why 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
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K Number
K042362Device 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
862.1160Why 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.
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K Number
K041926Device 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
862.1150Why 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
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