Search Filters

Search Results

Found 26 results

510(k) Data Aggregation

    K Number
    K003104
    Device Name
    BACT/ALERT CSR
    Manufacturer
    ORGANON TEKNIKA CORP.
    Date Cleared
    2000-10-20

    (52 days)

    Product Code
    LJF
    Regulation Number
    866.2560
    Why did this record match?
    Applicant Name (Manufacturer) :

    ORGANON TEKNIKA CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K000492
    Device Name
    MDA D-DIMER
    Manufacturer
    ORGANON TEKNIKA CORP.
    Date Cleared
    2000-06-07

    (113 days)

    Product Code
    DAP
    Regulation Number
    864.7320
    Why did this record match?
    Applicant Name (Manufacturer) :

    ORGANON TEKNIKA CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K000378
    Device Name
    BACT/ALERT MB CULTURE BOTTLE
    Manufacturer
    ORGANON TEKNIKA CORP.
    Date Cleared
    2000-03-02

    (24 days)

    Product Code
    MDB
    Regulation Number
    866.2560
    Why did this record match?
    Applicant Name (Manufacturer) :

    ORGANON TEKNIKA CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K994343
    Device Name
    BACT/ALERT SV
    Manufacturer
    ORGANON TEKNIKA CORP.
    Date Cleared
    2000-02-10

    (49 days)

    Product Code
    MDB
    Regulation Number
    866.2560
    Why did this record match?
    Applicant Name (Manufacturer) :

    ORGANON TEKNIKA CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The BacT/ALERT SV Culture Bottles are used with the BacT/ALERT Microbial Detection Systems in qualitative procedures for enhanced recovery and detection of aerobic and facultative anaerobic microorganisms (bacteria and fungi) from blood and other normally sterile body fluids.
    Device Description
    The BacT/ALERT SV Culture Bottle was developed for the same intended use as the current BacT/Alert Standard Aerobic Culture Bottle, to provide suitable nutritional and environmental conditions for organisms commonly encountered in blood infections and normally sterile body fluids. An inoculated bottle is placed into the BacT/ALERT Microbial Detection Instruments where it is incubated and continuously monitored for the presence of microorganisms that will grow in the BacT/ALERT SV Bottle.
    Ask a Question
    K Number
    K993423
    Device Name
    BACT/ALERT SA
    Manufacturer
    ORGANON TEKNIKA CORP.
    Date Cleared
    1999-12-15

    (64 days)

    Product Code
    MDB
    Regulation Number
    866.2560
    Why did this record match?
    Applicant Name (Manufacturer) :

    ORGANON TEKNIKA CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    BacT/ALERT SA Culture Bottles are used with the BacT/ALERT Microbial Detection Systems in qualitative procedures for the recovery and detection of aerobic microorganisms (bacteria and fungi) from blood and other normally sterile body fluids.
    Device Description
    The BacT/ALERT SA Culture Bottle was developed for the same intended use as the current BacT/Alert Standard Aerobic Culture Bottle, to provide suitable nutritional and environmental conditions for organisms commonly encountered in blood infections and normally sterile body fluids. An inoculated bottle is placed into the BacT/ALERT Microbial Detection Instruments where it is incubated and continuously monitored for the presence of microorganisms that will grow in the BacT/ALERT SA Bottle.
    Ask a Question
    K Number
    K993421
    Device Name
    BACT/ALERT SN
    Manufacturer
    ORGANON TEKNIKA CORP.
    Date Cleared
    1999-12-14

    (63 days)

    Product Code
    MDB
    Regulation Number
    866.2560
    Why did this record match?
    Applicant Name (Manufacturer) :

    ORGANON TEKNIKA CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The BacT/ALERT SN Culture Bottles are used with the BacT/ALERT Microbial Detection Systems in qualitative procedures for recovery and detection of anaerobic microorganisms (bacteria) from blood and other normally sterile body fluids.
    Device Description
    The BacT/ALERT SN Culture Bottle was developed for the same intended use as the current BacT/Alert Standard Anaerobic Culture Bottle, to provide suitable nutritional and environmental conditions for organisms commonly encountered in blood infections and normally sterile body fluids. An inoculated bottle is placed into the BacT/ALERT Microbial Detection Instruments where it is incubated and continuously monitored for the presence of microorganisms that will grow in the BacT/ALERT SN Bottle.
    Ask a Question
    K Number
    K993576
    Device Name
    BACT/ALERT MP PROCESS BOTTLE
    Manufacturer
    ORGANON TEKNIKA CORP.
    Date Cleared
    1999-12-14

    (54 days)

    Product Code
    MDB
    Regulation Number
    866.2560
    Why did this record match?
    Applicant Name (Manufacturer) :

    ORGANON TEKNIKA CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The BacT/ALERT MP Process Bottle is designed for use with the MB/BacT and the The DacT/ALERT 3D Mycobacteria Detection Systems, for recovery and detection of mycobacteria from sterile body specimens other than blood, and from digested-decontaminated clinical specimens.
    Device Description
    The BacT/ALERT MP Process Bottle was developed for the same intended use as the current MB/BacT Process Bottle, provide suitable nutritional and environmental conditions for mycobacterial organisms commonly encountered in body fluids. An inoculated bottle is placed into the MB/ BacT Detection Instrument or the BacT/ALERT 3D Instrument where it is incubated and continuously monitored for the presence of mycobacteria that will grow in the BacT/ALERT MP Process Bottle.
    Ask a Question
    K Number
    K992432
    Device Name
    BACT/ALERT FN
    Manufacturer
    ORGANON TEKNIKA CORP.
    Date Cleared
    1999-09-24

    (65 days)

    Product Code
    MDB
    Regulation Number
    866.2560
    Why did this record match?
    Applicant Name (Manufacturer) :

    ORGANON TEKNIKA CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The BacT/ALERT FN Culture Bottles are used with the BacT/ALERT Microbial Detection Systems in qualitative procedures for enhanced recovery and detection of anaerobic microorganisms from blood and other normally sterile body fluids.
    Device Description
    The BacT/ALERT FN Culture Bottle was developed for the same intended use as the current BacT/Alert FAN Anaerobic Culture Bottle, to provide suitable nutritional and environmental conditions for organisms commonly encountered in blood infections and normally sterile body fluids. An inoculated bottle is placed into the BacT/ALERT Microbial Detection Instrument where it is incubated and continously monitored for the presence of microorganisms that will grow in the BacT/ALERT FN Culture Bottle.
    Ask a Question
    K Number
    K983762
    Device Name
    NUCLISENS CMV PP67
    Manufacturer
    ORGANON TEKNIKA CORP.
    Date Cleared
    1999-09-15

    (324 days)

    Product Code
    LIN
    Regulation Number
    866.3175
    Why did this record match?
    Applicant Name (Manufacturer) :

    ORGANON TEKNIKA CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The NucliSens® CMV pp67 assay is a nucleic acid amplification-based qualitative assay to be used in conjunction with the NucliSens® Reader for the detection of human cytomegalovirus (HCMV) pp67 mRNA in EDTA anticoagulated whole blood from adult transplant donors and HIV infected individuals. It is intended as an aid in the diagnosis of active (acute or reactivated) HCMV infection. This product is not intended for use in screening of blood or plasma donors.
    Device Description
    The NucliSens® CMV pp67 assay is a nucleic acid amplification-based qualitative assay to be used in conjunction with the NucliSens®™ Reader for the detection of human cytomegalovirus (HCMV) pp67 mRNA in EDTA anticoagulated whole blood from adult transplant donors and HIV infected individuals. It is intended as an aid in the diagnosis of active (acute or reactivated) HCMV infection. This product is not intended for use in screening of blood or plasma donors. The NucliSens® CMV pp67 assay is comprised of four separate stages: - Nucleic acid release - Nucleic acid isolation - Nucleic acid amplification - Nucleic acid detection
    Ask a Question
    K Number
    K992400
    Device Name
    BACTALERT FA
    Manufacturer
    ORGANON TEKNIKA CORP.
    Date Cleared
    1999-09-03

    (46 days)

    Product Code
    MDB
    Regulation Number
    866.2560
    Why did this record match?
    Applicant Name (Manufacturer) :

    ORGANON TEKNIKA CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The BacT/ALERT FA Culture Bottles are used with the BacT/ALERT Microbial Detection Systems in qualitative procedures for enhanced recovery and detection of aerobic and facultative anaerobic microorganisms ( bacteria and fungi) from blood and other normally sterile body fluids.
    Device Description
    The BacT/ALERT FA Culture Bottle was developed for the same intended use as the current BacT/Alert FAN Aerobic Culture Bottle, to provide suitable nutritional and environmental conditions for organisms commonly encountered in blood infections and normally sterile body fluids. An inoculated bottle is placed into the BacT/ALERT Microbial Detection Instruments where it is incubated and continuously monitored for the presence of microorganisms that will grow in the BacT/ALERT FA Bottle.
    Ask a Question

    Page 1 of 3