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510(k) Data Aggregation

    K Number
    K992859
    Device Name
    ABL700 SERIES ANALYZER WITH AUTOCHECK MODULE
    Manufacturer
    RADIOMETER AMERICA, INC.
    Date Cleared
    2000-01-10

    (138 days)

    Product Code
    CHL, CEM, CGA, CGZ, GKF, JFP, JGS, JJS, KHP
    Regulation Number
    862.1120
    Why did this record match?
    Applicant Name (Manufacturer) :

    RADIOMETER AMERICA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ABL700 Series Analyzer with the AutoCheck module is a stand-alone blood gas analyzer that measures pH, pCO2, pO2, cNa+, cK+, cCa2+, cCL-, Glucose, Lactate, and Co-oximetry parameters on human arterial/venous and capillary whole blood. The AutoCheck Module is an added functionality to perform automated analysis of quality control fluids.
    Device Description
    The ABL700 Series Analyzer with the AutoCheck module is an ABL700 Analyzer with the added capability of performing automated analysis of quality control fluids. The AutoCheck module is designed to work with a quality control fluid system named AutoCheck 5+. The AutoCheck 5+ is an ampouled four level quality control fluid system. The composition of the various levels of Quality control fluids in AutoCheck 5+ correspond to the composition of the corresponding levels of Qualicheck 5+ system (K980135). The AutoCheck 5+ ampoules comprise a cap on the top of the ampoules designed to break the top of an ampoule when it is to be used. Furthermore, each ampoule has a bar code containing information on the specific level and lot of the quality control fluid. Installing an AutoCheck module into an existing ABL700 Series Analyzer includes physically installing the module and loading upgraded software which controls the function of the AutoCheck module. The AutoCheck module comprises an ampoule carrousel carrying 20 ampoules of quality control fluid and further comprises a bar code reader for reading the bar code located on each ampoule. When installed into the ABL700 Series Analyzer, the AutoCheck module automatically performs the quality control of the analyzer. Thus, when a quality control is due, the analyzer warns the user and if the user accepts, the quality control is performed. The software selects the appropriate ampoule, the AutoCheck module opens the ampoule by pressing the cap through the top of the ampoule, the quality control fluid is automatically introduced into the analyzer inlet and the measurements are performed. The upgraded software controls all steps. If required, a manual quality control may be performed as well.
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    K Number
    K991417
    Device Name
    ABL 735 ANALYZER
    Manufacturer
    RADIOMETER AMERICA, INC.
    Date Cleared
    1999-11-24

    (215 days)

    Product Code
    CHL, CEM, CGA, CGZ, CIG, JFP, JGS, MQM
    Regulation Number
    862.1120
    Why did this record match?
    Applicant Name (Manufacturer) :

    RADIOMETER AMERICA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ABL735 is intended for in vitro testing of samples of whole blood for the parameters pH, pO₂, pCO₂, potassium, sodium, calcium, chloride, glucose, lactate, total bilirubin, and co-oximetry parameters (total hemoglobin, oxygen saturation and the hemoglobin fractions FO₂Hb, FCOHb, FMetHb, FHHb, and FHHbF).
    Device Description
    ABL735 is an automated pH/Blood Gas/Co-oximetry/Electrolyte/Metabolite Analyzer that is 44cm X 70cm X 50cm (HWD) and weighs 30kg. It measures on whole blood in approximately 60 seconds.
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    K Number
    K982928
    Device Name
    NPT7 SERIES PH/BLOOD GAS AND CO-OXIMETRY SYSTEM
    Manufacturer
    RADIOMETER AMERICA, INC.
    Date Cleared
    1999-01-06

    (139 days)

    Product Code
    CHL, CEM, CGA, CGZ, GKF, JGS, JHP, KHP
    Regulation Number
    862.1120
    Why did this record match?
    Applicant Name (Manufacturer) :

    RADIOMETER AMERICA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    NPT7 Series is a stand-alone blood gas analyzer that measures pH, pCO2 pO2 ,and Co-oximetry parameters on human arterial/venous and capillary whole blood. The NPT7 Near Patient Testing System in its various configurations is intended for use in laboratory and point-of-care testing of pH, blood gases and co-oximetry parameters on whole blood samples by minimally trained personnel. The device is designed for stationary use as well as use in moving vehicles and air crafts.
    Device Description
    NPT7 Series is a stand-alone blood gas analyzer
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    K Number
    K980130
    Device Name
    ABL700 SERIES BLOOD GAS , CO-OXIMETRY, ELECTROLYTE & METABOLITE SYSTEM
    Manufacturer
    RADIOMETER AMERICA, INC.
    Date Cleared
    1998-02-09

    (26 days)

    Product Code
    CHL, CEM, CGA, CGZ, JFP, JGS, KHP
    Regulation Number
    862.1120
    Why did this record match?
    Applicant Name (Manufacturer) :

    RADIOMETER AMERICA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    ABL700 Series is a stand-alone blood gas analyzer that measures pH, pCO2, pO2 cNat, cK+, cCa+, cCL;, Glucose, Lactate, and Co-oximetry parameters on human arterial/venous and capillary whole blood, and pO2 and pCO2 on expired air.
    Device Description
    ABL700 Series, is an automated blood gas, co-oximetry electrolyte and metabolite analyzer that is 44 cm x 70 cm x 50 cm (HWD) and weighs 30 kg. It measures on whole blood in approximately 60 seconds.
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    K Number
    K980135
    Device Name
    QUALICHECK5+ MODELS S7730, S7740, S7750, S7760
    Manufacturer
    RADIOMETER AMERICA, INC.
    Date Cleared
    1998-01-28

    (13 days)

    Product Code
    JJS
    Regulation Number
    862.1660
    Why did this record match?
    Applicant Name (Manufacturer) :

    RADIOMETER AMERICA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Qualicheck5+ is a liquid, four ampoule quality control system, for checking the precision and accuracy of Radiometer and non-Radiometer analyzers for pH/Blood gases, Co-oximetry, Electrolytes, Glucose and Lactate.
    Device Description
    Qualicheck5+ is a four level quality control system consisting of part numbers S7730, S7740, S7750 and S7760. Each level consists of 30 ampoules per box.
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    K Number
    K974818
    Device Name
    ABL555 BLOOD GAS, ELECTROLYTE & METABOLITE SYSTEM
    Manufacturer
    RADIOMETER AMERICA, INC.
    Date Cleared
    1998-01-16

    (24 days)

    Product Code
    MMI
    Regulation Number
    862.1215
    Why did this record match?
    Applicant Name (Manufacturer) :

    RADIOMETER AMERICA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    ABL555 is a stand alone, blood gas, electrolyte and metabolite analyzer that measures pH, pCO2, pO2 Na+, K+, Hct, and the option of one of the following parameters: ClT or Ca2 or glucose or lactate.
    Device Description
    ABL555 is an automated blood gas, electrolyte and metabolite analyzer that is 40 cm x 55 cm x 40 cm (WHD) and weighs 37.5 kg. It measures on whole blood in approximately 54 seconds.
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    K Number
    K973367
    Device Name
    ABL555 BLOOD GAS, ELECTROLYTE & METABOLITE SYSTEM
    Manufacturer
    RADIOMETER AMERICA, INC.
    Date Cleared
    1997-10-06

    (28 days)

    Product Code
    CHL, CEM, CGA, JGS
    Regulation Number
    862.1120
    Why did this record match?
    Applicant Name (Manufacturer) :

    RADIOMETER AMERICA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    ABL555 is a stand alone, blood gas, electrolyte and metabolite analyzer that measures pH, pCO2, pO2 Na+, K+, and glucose on whole blood.
    Device Description
    ABL555 is an automated blood gas, electrolyte and metabolite analyzer that is 40 cm x 55 cm x 40 cm (WHD) and weighs 37.5 kg. It measures on whole blood in approximately 54 seconds.
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    K Number
    K962158
    Device Name
    PICO MODELS 30, 50, 70
    Manufacturer
    RADIOMETER AMERICA, INC.
    Date Cleared
    1996-10-29

    (147 days)

    Product Code
    JKA
    Regulation Number
    862.1675
    Why did this record match?
    Applicant Name (Manufacturer) :

    RADIOMETER AMERICA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Arterial blood sampler for pH, blood gas, oximetry, electrolyte and metabolite analyses.
    Device Description
    Preheparinized, electrolyte balanced, arterial blood sampler for pH, blood gas, oximetry, electrolyte and metabolite analyses. Available in multiple sizes and product versions.
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    K Number
    K962334
    Device Name
    EML105 ELECTROLYTE METABOLITE ANALYZER
    Manufacturer
    RADIOMETER AMERICA, INC.
    Date Cleared
    1996-10-24

    (129 days)

    Product Code
    JGS, CEM, CGA, CGZ, JFP, KHP
    Regulation Number
    862.1665
    Why did this record match?
    Applicant Name (Manufacturer) :

    RADIOMETER AMERICA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    EML105 is a stand alone, electrolyte metabolite analyzer that measures Na , K+, Ca2+, CI, glucose and lactate on whole blood and urine. It can be interfaced with an ABL analyzer 500/510/520 to become an ABL System 605/615/625 for the measurement of pH/Blood gases, electrolytes, metabolites and co-oximetry.
    Device Description
    EML105 is an automated electrolyte metabolite analyzer that is 40 cm x 35 cm x 40 cm (WHD) and weighs 22 kg. It measures on whole blood and urine in approximately 54 seconds.
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    K Number
    K961354
    Device Name
    QUALICHECK 4 METABOLITE(S3630,S3640,S3650,S3660)
    Manufacturer
    RADIOMETER AMERICA, INC.
    Date Cleared
    1996-06-14

    (67 days)

    Product Code
    JJS
    Regulation Number
    862.1660
    Why did this record match?
    Applicant Name (Manufacturer) :

    RADIOMETER AMERICA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Qualicheck 4 Metabolite is intended for checking the precision and accuracy of Radiometer and non-Radiometer analyzers for pH/Blood Gases, Electrolytes, Glucose and Lactate.
    Device Description
    Qualicheck 4 Metabolite is a four level quality control system consisting of part numbers S3630, S3640, S3650, and S3660. Each level consists of 30 ampoules per box, 2 mL solution per ampoule.
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