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510(k) Data Aggregation

    K Number
    K024182
    Device Name
    PRECISION SYSTEMS ANALETTE CHEMISTRY ANALYZER STANBIO LABORATORY REAGENTS
    Manufacturer
    PRECISION SYSTEMS, INC.
    Date Cleared
    2003-03-03

    (74 days)

    Product Code
    CDQ, CEO, CGA, CGS, CGX, CHH, CHJ, CIG, CIT, CIX, CJE, CJY, JGJ, JGY, JJF, KNK
    Regulation Number
    862.1770
    Why did this record match?
    Applicant Name (Manufacturer) :

    PRECISION SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    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
    K022072
    Device Name
    PRECISION SYSTEMS ANALETTE CHEMISTRY ANALYZER & MEDICAL ANALYSIS SYSTEMS REAGENTS
    Manufacturer
    PRECISION SYSTEMS, INC.
    Date Cleared
    2002-08-23

    (58 days)

    Product Code
    CIX, CDQ, CEK, CEO, CET, CGS, CGZ, CHH, CIG, CIT, CJE, CKA, GGY, JFJ, JGJ, JGY, JQB, KHS, KNK
    Regulation Number
    862.1035
    Why did this record match?
    Applicant Name (Manufacturer) :

    PRECISION SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    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.
    Ask a Question
    K Number
    K013654
    Device Name
    PRECISION SYSTEMS ANALETTE CHEMISTRY ANALYZER
    Manufacturer
    PRECISION SYSTEMS, INC.
    Date Cleared
    2002-06-05

    (211 days)

    Product Code
    JJF, CDQ, CEK, CEO, CFJ, CFM, CGA, CHG, CHH, CIG, CIT, CIX, CJE, CJY, CKA, GGX, JFJ, JGJ, JGY, JMO, JQB, KHS, KNK, LBR
    Regulation Number
    862.2170
    Why did this record match?
    Applicant Name (Manufacturer) :

    PRECISION SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    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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