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510(k) Data Aggregation
K Number
K992846Device Name
HICHEM TOTAL PROTEIN REAGENT
Manufacturer
ELAN HOLDINGS, INC.
Date Cleared
1999-10-18
(55 days)
Product Code
CEK
Regulation Number
862.1635Why did this record match?
Product Code :
CEK
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
HiChem® Total Protein Reagent is intended for the quantitative determination of total protein in serum and plasma on the SYNCHRON CX® Systems and serum, plasma and cerebrospinal fluid on the SYNCHRON CX® DELTA Systems. Total protein results are used in the diagnosis and treatment of a variety of diseases involving the liver, kidney, or bone marrow as well as other metabolic or nutritional disorders. This reagent is intended for professional use only.
Device Description
HiChem® Total Protein Reagent is intended for the quantitative determination of total protein in serum and plasma on the SYNCHRON CX® Systems and serum, plasma and cerebrospinal fluid on the SYNCHRON CX® DELTA Systems.
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K Number
K973108Device Name
TOTAL PROTEIN (MICRO) ASSAY, CATALOGUE NUMBER 450-50
Manufacturer
DIAGNOSTIC CHEMICALS LTD.
Date Cleared
1998-03-02
(195 days)
Product Code
CEK
Regulation Number
862.1635Why did this record match?
Product Code :
CEK
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
For the quantitative determination of Total Protein in urine and cerebrospinal fluid (CSF). For IN VITRO diagnostic use.
Device Description
Total Protein (Micro) Assay
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K Number
K980042Device Name
CARESIDE TOTAL PROTEIN
Manufacturer
EXIGENT DIAGNOSTICS, INC.
Date Cleared
1998-02-04
(29 days)
Product Code
CEK
Regulation Number
862.1635Why did this record match?
Product Code :
CEK
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
For in vitro diagnostic use with Exigent Diagnostics CareSide™ Analyzer to measure total protein from whole blood, heparinized plasma or serum specimens by professionals to aid in the diagnosis and treatment of a variety of diseases involving the liver, kidney, or bone marrow as well as other metabolic or nutritional disorders.
Device Description
CareSide™ Total Protein cartridges are used with the Exigent Diagnostics CareSide™ Analyzer to measure total protein concentration in whole blood, plasma or serum specimens. The CareSide™ Total Protein cartridge, a single use disposable in vitro diagnostic test carridge, aids in specimen separation and delivers a measured volume of plasma or serum to a dry film to initiate the measurement of total protein concentration. The film cartridge (patent pending) contains all reagents necessary to measure total protein concentration. When used in conjunction with the CareSide™ Albumin cartidge on the CareSide™ Analyzer, the analyzer calculates globulin (as the difference between the total protein and albumin concentrations) and the albumin/globulin ratio (A/G ratio).
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K Number
K971524Device Name
TOTAL PROTEIN OR TP
Manufacturer
CAROLINA LIQUID CHEMISTRIES CORP.
Date Cleared
1997-05-16
(18 days)
Product Code
CEK
Regulation Number
862.1635Why did this record match?
Product Code :
CEK
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K961864Device Name
CSF/URINE TOTAL PROTEIN
Manufacturer
TECO DIAGNOSTICS
Date Cleared
1996-10-24
(163 days)
Product Code
CEK
Regulation Number
862.1635Why did this record match?
Product Code :
CEK
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K955905Device Name
STC DIAGNOSTICS AUTO-LYTE URINARY PROTEIN ASSAY
Manufacturer
SOLARCARE TECHNOLOGIES CORP,INC.
Date Cleared
1996-05-30
(153 days)
Product Code
CEK
Regulation Number
862.1635Why did this record match?
Product Code :
CEK
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K955936Device Name
TOTAL PROTEIN REAGENT
Manufacturer
DERMA MEDIA LAB., INC.
Date Cleared
1996-03-12
(82 days)
Product Code
CEK
Regulation Number
862.1635Why did this record match?
Product Code :
CEK
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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