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510(k) Data Aggregation
K Number
K024182Device Name
PRECISION SYSTEMS ANALETTE CHEMISTRY ANALYZER STANBIO LABORATORY REAGENTS
Manufacturer
Date Cleared
2003-03-03
(74 days)
Regulation Number
862.1770Why did this record match?
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Matched: '862.2500'
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Precision Systems™ ANALETTE™ Chemistry Analyzer is intended for the quantitative determination of Calcium, Creatinine, Phosphorus, Albumin, Total Protein, Glucose, Urea Nitrogen, Magnesium, Creatine Kinase, Alkaline Phosphatase, Cholesterol(includes HDL), Triglycerides, Total Bilirubin, Direct Bilirubin, Uric Acid, Lactate Dehydrogenase L, Alanine Aminotransferase, Aspartate Aminotransferase, Gamma Glutamyl Transferase, Chloride, and etc. analytes in solution such as serum, plasma, or urine. It is an "open" System, which can use a variety of commercially manufactured reagents such as but not limited to Synermeds® Reagents, Medical Analysis Systems Reagents and STANBIO Laboratory Reagents. It is used to monitor various physiological diseases or conditions. Precision Systems Inc will distribute, recommend and sales STANBIO Reagents without any modification of STANBIO packaging using PSI Applications sheets.
Device Description
The ANALETTE™ Chemistry Analyzer is an in vitro diagnostic automated clinical chemistry analyzer for the analysis of analytes in solution. It is an "open" System, which can use a variety of commercially manufactured reagents.
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K Number
K022072Device Name
PRECISION SYSTEMS ANALETTE CHEMISTRY ANALYZER & MEDICAL ANALYSIS SYSTEMS REAGENTS
Manufacturer
Date Cleared
2002-08-23
(58 days)
Regulation Number
862.1035Why did this record match?
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Matched: '862.2500'
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Precision Systems™ ANALETTE™ Chemistry Analyzer is intended for the quantitative determination of Calcium, Creatinine, Phosphorus, Albumin, Total Protein, Glucose, Urea Nitrogen, Magnesium, Creatine Kinase, Alkaline Phosphatase, Carbon Dioxide, Amylase, Cholesterol(includes HDL), Triglycerides, Total Bilirubin, Direct Bilirubin, Uric Acid, Lactate Dehydrogenase L, Lactate Dehydrogenase P, Alanine Aminotransferase. Aspartate Aminotransferase; Gamma Glutamyl Transferase, Lipase, Chloride, and etc. analytes in solution such as serum, plasma, or urine. It is an "open" System, which can use a variety of commercially manufactured reagents such as but not limited to Synermeds® Reagents and Medical Analysis Systems Reagents. It is used to monitor various physiological diseases or conditions. Precision Systems Inc will distribute, recommend and sales MAS Reagents without any modification of MAS packaging using PSI Applications sheets.
Device Description
An in vitro diagnostic automated clinical chemistry analyzer for the analysis of analytes in solution.
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K Number
K013654Device Name
PRECISION SYSTEMS ANALETTE CHEMISTRY ANALYZER
Manufacturer
Date Cleared
2002-06-05
(211 days)
Regulation Number
862.2170Why did this record match?
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Matched: '862.2500'
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Precision Systems ANALETTE Chemistry Analyzer is intended for the quantitative determination of analytes in solutions, such as serum, plasma, or urine. It is an "open" system, which can use a variety of commercially manufactured reagents, such as, but not limited to Synermed's Reagents for Albumin, ALT, AST, ALP, Amylase, Calcium, CO2, Cholesterol, Creatinine, CK, Glucose, GGT, LDH, Maqnesium, Phosphorus, Total Protein, Triglycerides, Urea Nitrogen, Total Bilirubin, Direct Bilirubin, HDL Cholesterol, UBIC, Iron, Chloride, and Uric Acid as shown in 510(k) K971491 using the ANALETTE under Synermed's name IR 200
Device Description
An in vitro diagnostic automated clinical chemistry analyzer for the analysis of analytes in solution.
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K Number
K980757Device Name
ILAB 600 CLINICAL CHEMISTRY SYSTEM
Manufacturer
Date Cleared
1998-04-21
(53 days)
Regulation Number
862.1170Why did this record match?
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Matched: '862.2500'
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The ILab 600 is an automated, random access clinical chemistry analyzer which uses analytical techniques (photometry and potentiometry) for the in vitro quantitation of analytes found in physiological fluids such as serum, plasma, urine and cerebrospinal fluid. The results of the measurements are used as medical diagnostic tools.
Device Description
The ILab 600 is an automated, random access clinical chemistry analyzer which uses analytical techniques (photometry and potentiometry) for the in virro quantitation of analytes found in physiological fluids such as serum, plasma, urine and cerebrospinal fluid. The results of the measurements are used as medical diagnostic tools.
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