Search Filters

Search Results

Found 10 results

510(k) Data Aggregation

    K Number
    K030799
    Device Name
    MICROS 60
    Manufacturer
    ABX DIAGNOSTICS
    Date Cleared
    2003-04-08

    (26 days)

    Product Code
    GKZ
    Regulation Number
    864.5220
    Why did this record match?
    Applicant Name (Manufacturer) :

    ABX DIAGNOSTICS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ABX MICROS 60 Hematology Analyzer is a fully automated (microprocessor controlled) hematology analyzer used for the in vitro diagnostic testing of whole blood specimens or blood cell concentrates. It operates in complete blood count (CBC) mode.
    Device Description
    The ABX MICROS 60 device is a benchtop, clinical laboratory instruments that analyze in-vitro samples of whole blood specimens. The device operates in a complete blood count (CBC) and 3 part DIFF (LMG). As either a closed tube / closed system (CT/CS) or open tube/open system (OT/OS). The ABX MICROS 60 can evaluate 5,8, 16 or 18 hematology parameters depending on its internal configuration.
    Ask a Question
    K Number
    K030144
    Device Name
    MODIFICATION TO PENTRA 60 AND PENTRA 60C+
    Manufacturer
    ABX DIAGNOSTICS
    Date Cleared
    2003-01-31

    (16 days)

    Product Code
    GKZ
    Regulation Number
    864.5220
    Why did this record match?
    Applicant Name (Manufacturer) :

    ABX DIAGNOSTICS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ABX PENTRA 60 and 60C+ Hematology Analyzer are fully automated (microprocessor controlled) hematology analyzer used for the in vitro diagnostic testing of whole blood specimens. The ABX PENTRA 60 and 60C+ Hematology Analyzer are able to operate either in complete blood count (CBC) mode or in CBC + 5 differential leucocyte count (5DIFF) mode.
    Device Description
    The ABX PENTRA 60 & PENTRA 60C+ are benchtop, clinical laboratory instrument which analyzes in-vitro samples of whole blood to provide complete blood count and leucocyte differential count using principles of cytochemistry, focused flow impedance and light transmission using a halogen light source. The PENTRA 60 is an standalone device using a keyboard and LCD screen integrated into the device. Whereas the PENTRA 60C+ is the PENTRA 60 connected to a dedicated workstation with user interfacing software.
    Ask a Question
    K Number
    K024002
    Device Name
    PENTRA 80
    Manufacturer
    ABX DIAGNOSTICS
    Date Cleared
    2003-01-03

    (30 days)

    Product Code
    GKZ
    Regulation Number
    864.5220
    Why did this record match?
    Applicant Name (Manufacturer) :

    ABX DIAGNOSTICS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ABX PENTRA 80 Hematology Analyzer is a fully automated (microprocessor controlled) hematology analyzer used for the in vitro diagnostic testing of whole blood specimens. The ABX PENTRA 80 is able to operate either in complete blood count (CBC) mode or in CBC + 5 differential leucocyte count (5DIFF) mode.
    Device Description
    The PENTRA 80 Hematology analyzer is a benchtop, clinical laboratory instrument which analyzes in-vitro samples of whole blood to provide complete blood count and leucocyte differential count using principles of cytochemistry, focused flow impedance and light transmission using a halogen light source. The instrument is microprocessor driven, with an internal PC that performs further data processing and hosts the user interface.
    Ask a Question
    K Number
    K022200
    Device Name
    PENTRA 120/PENTRA 120 RETIC OPTIONS SPS, MODEL PENTRA 120
    Manufacturer
    ABX DIAGNOSTICS
    Date Cleared
    2002-07-29

    (24 days)

    Product Code
    GKZ, GKJ, KPA
    Regulation Number
    864.5220
    Why did this record match?
    Applicant Name (Manufacturer) :

    ABX DIAGNOSTICS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ABX PENTRA 120 Hematology Analyzer is an automated hematology analyzer providing complete blood count (CBC) and differential leucocyte count (DIFF) for the in vitro diagnostic use in clinical laboratories. The ABX PENTRA 120 RETIC Hematology Analyzer is an automated hematology analyzer providing complete blood count (CBC), differential leucocyte count (DIFF) as well as reticulocyte count (RET) for the in vitro diagnostic use in clinical laboratories. The clinical use in the ABX PENTRA 120 RETIC Hematology Analyzer of the reticulocyte count, specifically the immature reticulocyte fraction (IRF), is to monitor erythropoietic activity in patients. The option of the SPS (Slide Preparation System) smears and stains on a clean microscope slide.
    Device Description
    The PENTA 120 / P120 RETIC Automated Hematology Analyzer is a bench-top, clinical laboratory instrument which analyzes in-vitro samples of whole blood to provide complete blood count, leukocyte differential count and reticulocyte count using principles of cytochemistry, focused flow impedance, light absorbance and fluorescence. The instrument is microprocessor driven. Controlled by the PENTRA 120 the optional device SPS (Slide Preparation System) smears and stains the slides.
    Ask a Question
    K Number
    K014203
    Device Name
    ABX MICROS 60 HEMATOLOGY ANALYZER
    Manufacturer
    ABX DIAGNOSTICS
    Date Cleared
    2002-02-28

    (69 days)

    Product Code
    GKX, GKZ
    Regulation Number
    864.5200
    Why did this record match?
    Applicant Name (Manufacturer) :

    ABX DIAGNOSTICS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ABX MICROS 60 Hematology Analyzer is a fully automated (microprocessor controlled) hematology analyzer used for the in vitro diagnostic testing of whole blood specimens or blood cell concentrates. It operates in complete blood count (CBC) mode.
    Device Description
    The ABX MICROS 60 Hematology Analyzer is a bench top clinical laboratory instrument which analyzes in vitro samples of whole blood to provide complete blood count data using principles of cytochemistry, focused flow impedance, and light transmission technology. The system is equipped with automatic calibration; Automated smart cards based for: calibration, QC with 93 multiple range files and memory with 60 erasable results.
    Ask a Question
    K Number
    K003677
    Device Name
    ABX PENTRA 60C+ HEMATOLOGY ANALYZER
    Manufacturer
    ABX DIAGNOSTICS
    Date Cleared
    2000-12-26

    (27 days)

    Product Code
    GKZ
    Regulation Number
    864.5220
    Why did this record match?
    Applicant Name (Manufacturer) :

    ABX DIAGNOSTICS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K002646
    Device Name
    ABX MICROS CRP
    Manufacturer
    ABX DIAGNOSTICS
    Date Cleared
    2000-10-26

    (63 days)

    Product Code
    GKZ
    Regulation Number
    864.5220
    Why did this record match?
    Applicant Name (Manufacturer) :

    ABX DIAGNOSTICS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K992511
    Device Name
    ABX PENTRA 60 HEMATOLOGY ANALYZER
    Manufacturer
    ABX DIAGNOSTICS
    Date Cleared
    1999-10-15

    (80 days)

    Product Code
    GKZ
    Regulation Number
    864.5220
    Why did this record match?
    Applicant Name (Manufacturer) :

    ABX DIAGNOSTICS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ABX PENTRA 60™ Hematology Analyzer is a fully automated (microprocessor controlled) hematology analyzer used for the in vitro diagnostic testing of whole blood specimens. The ABX PENTRA 60™ is able to operate either in complete blood count (CBC) mode or in CBC + 5 differential leucocyte count (5DIFF) mode.
    Device Description
    The ABX PENTRA 60™ Hematology Analyzer is a benchtop, clinical laboratory instrument which analyzes in-vitro samples of whole blood to provide complete blood count and leucocyte differential count using principles of cytochemistry, focused flow impedance and light transmission using a halogen light source. The instrument is microprocessor driven.
    Ask a Question
    K Number
    K991839
    Device Name
    ABX PENTRA 120 RETIC AUTOMATED HEMATOLOGY ANALYZER
    Manufacturer
    ABX DIAGNOSTICS
    Date Cleared
    1999-08-11

    (75 days)

    Product Code
    GKZ
    Regulation Number
    864.5220
    Why did this record match?
    Applicant Name (Manufacturer) :

    ABX DIAGNOSTICS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ABX PENTRA 120 RETIC Automated Hematology Analyzer is an automated hematology analyzer providing complete blood count (CBC), differential leucocyte count (DIFF) as well as reticulocyte count for in vitro diagnostic use in clinical laboratories. The ABX PENTRA 120 RETIC Automated Hematology Analyzer provides appropriate flags and alarms to assist users in final checking and identification of abnormal cell populations. The clinical use of the reticulocyte count, specifically the immature reticulocyte fraction (IRF), is to monitor erythropoietic activity in patients.
    Device Description
    The ABX PENTRA 120 RETIC Automated Hematology Analyzer is a benchtop, clinical laboratory instrument which analyzes in-vitro samples of whole blood to provide complete blood count, leucocyte differential count and reticulocyte count using principles of cytochemistry, focused flow impedance, light scattering, and fluorescence. The instrument is microprocessor driven.
    Ask a Question
    K Number
    K990311
    Device Name
    VEGA RETIC AUTOMATED HEMATOLOGY ANALYZER
    Manufacturer
    ABX DIAGNOSTICS
    Date Cleared
    1999-03-31

    (58 days)

    Product Code
    GKZ
    Regulation Number
    864.5220
    Why did this record match?
    Applicant Name (Manufacturer) :

    ABX DIAGNOSTICS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The VEGA RETIC Automated Hematology Analyzer is an automated hematology analyzer providing complete blood count (CBC), differential leucocyte count (DIFF) as well as reticulocyte count for in vitro diagnostic use in clinical laboratories. The VEGA RETIC Automated Hematology Analyzer provides appropriate flags and alarms to assist users in final checking and identification of abnormal cell populations.
    Device Description
    The VEGA RETIC Automated Hematology Analyzer is a benchtop, clinical laboratory instrument which analyzes in-vitro samples of whole blood to provide complete blood count, leucocyte differential count and reticulocyte count using principles of cytochemistry, focused flow impedance, light scattering, and fluorescence. The instrument is microprocessor driven.
    Ask a Question

    Page 1 of 1