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Found 19 results
510(k) Data Aggregation
K Number
K133519Device Name
CAROLINA LIQUID CHEMISTRIES CLC 6410 CHEMISTRY ANALYZER; CAROLINA LIQUID CHEMISTRIES GLUCOSE REAGENT, CAR
Manufacturer
CAROLINA LIQUID CHEMISTRIES CORP.
Date Cleared
2014-05-16
(182 days)
Product Code
JJE, CEM, CFR, CGZ, JGS, JIX
Regulation Number
862.2160Why did this record match?
Applicant Name (Manufacturer) :
CAROLINA LIQUID CHEMISTRIES CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Carolina Liquid Chemistries CLC 6410 chemistry analyzer is an automated clinical analyzer for in vitro diagnostic use only in clinical laboratories. It is intended to be used for a variety of assay methods. The analyzer provides in vitro quantitative determinations for glucose, sodium, potassium, and chloride in serum and plasma samples.
The Carolina Liquid Chemistries Glucose Reagent is for use with the Carolina Liquid Chemistries CLC 6410 Chemistry Analyzer for the measurement of glucose in serum and plasma. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and of pancreatic islet cell carcinoma.
The Carolina Liquid Chemistries ISE Kit is intended to be used with the Carolina Liquid Chemistries CLC 6410 Chemistry Analyzer for measurement of sodium, potassium, and chloride in serum and plasma. The ISE Kit consists of ISE Buffer, internal reference solution, and reference solution. Sodium measurements are used in the diagnosis and treatment of diseases involving electrolyte imbalance. Potassium measurements monitor electrolyte balance and in the diagnosis and treatment of disease conditions characterized by low or high blood potassium levels. Chloride measurements are used for the diagnosis and treatment of electrolyte and metabolic disorders.
The Carolina Liquid Chemistries ISE Calibrator Kit consists of Calibrator 1, Calibrator 2, and Selectivity Check. It is used with the ISE Module on the Carolina Liquid Chemistries CLC 6410 Chemistry Analyzer for the calibration of the Sodium, Potassium and Chloride assays.
For in vitro diagnostic use only.
Device Description
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K Number
K132711Device Name
CAROLINA LIQUID CHEMISTRIES HDL CHOLESTEROL REAGENT
Manufacturer
CAROLINA LIQUID CHEMISTRIES CORP.
Date Cleared
2014-05-08
(252 days)
Product Code
LBS
Regulation Number
862.1475Why did this record match?
Applicant Name (Manufacturer) :
CAROLINA LIQUID CHEMISTRIES CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
For the quantitative determination of high-density lipprotein cholesterol (HDL-C) in serum using the Carolina Liquid Chemistries CLC720® Clinical Chemistry Analyzer. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases. For in vitro diagnostic use only.
Device Description
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K Number
K971907Device Name
CALCIUM REAGENT
Manufacturer
CAROLINA LIQUID CHEMISTRIES CORP.
Date Cleared
1997-06-24
(32 days)
Product Code
CIC
Regulation Number
862.1145Why did this record match?
Applicant Name (Manufacturer) :
CAROLINA LIQUID CHEMISTRIES CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Calcium Reagent is intended for the quantitative determination of serum calcium using the Beckman SYNCHRON CX Clinical Systems. The results are used in the diagnosis and treatment of hyperparathyroidism, hypoparathyroidism, multiple myeloma, nephrosis, nephritis, pancreatitis and hypervitaminosis D.
Device Description
Calcium Reagent
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K Number
K972073Device Name
TOTAL BILIRUBIN REAGENT
Manufacturer
CAROLINA LIQUID CHEMISTRIES CORP.
Date Cleared
1997-06-24
(21 days)
Product Code
CIG
Regulation Number
862.1110Why did this record match?
Applicant Name (Manufacturer) :
CAROLINA LIQUID CHEMISTRIES CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Total Bilirubin is intended for the quantitative determination of total bilirubin in serum using Beckman SYNCHRON CX Clinical Systems. The results are used in the diagnosis and treatment of liver, hemolytic hematological, and metabolic disorders, including hepatitis and gall bladder block.
Device Description
Total Bilirubin Reagent
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K Number
K971324Device Name
TRIGLYCERIDES, TG, OR TRIG
Manufacturer
CAROLINA LIQUID CHEMISTRIES CORP.
Date Cleared
1997-06-20
(71 days)
Product Code
CDT
Regulation Number
862.1705Why did this record match?
Applicant Name (Manufacturer) :
CAROLINA LIQUID CHEMISTRIES CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Triglycerides Reagent is intended for the quantitative determination of serum triglycerides using the Beckman SYNCHRON CX Clinical System:s. Elevated serum triglyceride levels are associated with increased risk of coronary artery disease, pancreatitis, and numerous genetic lipoprotein disorders.
Device Description
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K Number
K971908Device Name
CREA OR CREATININE
Manufacturer
CAROLINA LIQUID CHEMISTRIES CORP.
Date Cleared
1997-06-17
(25 days)
Product Code
CGX
Regulation Number
862.1225Why did this record match?
Applicant Name (Manufacturer) :
CAROLINA LIQUID CHEMISTRIES CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Creatinine Reagent is intended for the quantitative determination of serum creatinine using the Beckman SYNCHRON CX Clinical Systems. The results are used in the diagnosis and treatment of renal malfunction.
Device Description
Creatinine Reagent
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K Number
K971967Device Name
BUN
Manufacturer
CAROLINA LIQUID CHEMISTRIES CORP.
Date Cleared
1997-06-17
(20 days)
Product Code
CDQ
Regulation Number
862.1770Why did this record match?
Applicant Name (Manufacturer) :
CAROLINA LIQUID CHEMISTRIES CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
BUN Reagent is intended for the quantitative determination of urea nitrogen in serum using Beckman SYNCHRON CX Clinical Systems. The results are used in the diagnosis and treatment of certain renal and metabolic diseases.
Device Description
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K Number
K971467Device Name
SYNCHRON CX SYSTEMS GLUCOSE REAGENT (GLU)
Manufacturer
CAROLINA LIQUID CHEMISTRIES CORP.
Date Cleared
1997-06-16
(55 days)
Product Code
CFR
Regulation Number
862.1345Why did this record match?
Applicant Name (Manufacturer) :
CAROLINA LIQUID CHEMISTRIES CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Glucose Reagent is intended for the quantitative determination of serum glucose using the Beckman SYNCHRON CX Clinical Systems. The results are used in the diagnosis and treatment of diabetes mellitus, neonatal and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.
Device Description
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K Number
K971345Device Name
CHOL OR CHOLESTEROL
Manufacturer
CAROLINA LIQUID CHEMISTRIES CORP.
Date Cleared
1997-05-29
(49 days)
Product Code
CHH
Regulation Number
862.1175Why did this record match?
Applicant Name (Manufacturer) :
CAROLINA LIQUID CHEMISTRIES CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Cholesterol Reagent is intended for the quantitative determination of serum total cholesterol using Beckman SYNCHRON CX Systems. The results are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood as well as lipid and lipoprotein metabolism disorders.
Device Description
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K Number
K971396Device Name
CK REAGENT
Manufacturer
CAROLINA LIQUID CHEMISTRIES CORP.
Date Cleared
1997-05-29
(44 days)
Product Code
CGS
Regulation Number
862.1215Why did this record match?
Applicant Name (Manufacturer) :
CAROLINA LIQUID CHEMISTRIES CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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