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510(k) Data Aggregation

    K Number
    K971220
    Device Name
    GREINER VACUETTE BLOOD COLLECTION TUBE
    Manufacturer
    GREINER AMERICA, INC.
    Date Cleared
    1997-06-04

    (63 days)

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

    GREINER AMERICA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    To evaluate blood-sedimentation-rates
    Device Description
    The Greiner Vacuette® ESR blood collection tube with citrate solution is an evacuated blood collection device intended for use in evaluations of blood sedimentation rate.
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    K Number
    K971236
    Device Name
    GREINER VACUETTE BLOOD COLLECTION TUBE
    Manufacturer
    GREINER AMERICA, INC.
    Date Cleared
    1997-05-12

    (40 days)

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

    GREINER AMERICA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Greiner Vacuette® blood collection tube with EDTA K2 is an evacuated blood collection device containing EDTA K2 anticoagulant additive and intended for use in evaluations of whole blood specimens.
    Device Description
    The Greiner Vacuette® blood collection tube with EDTA K2 is an evacuated blood collection device containing EDTA K2 anticoagulant additive. The tube material is clear plastic.
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    K Number
    K971239
    Device Name
    GREINER VACUETTE BLOOD COLLECTION TUBE
    Manufacturer
    GREINER AMERICA, INC.
    Date Cleared
    1997-05-12

    (40 days)

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

    GREINER AMERICA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    evacuated blood collection devices intended for use in testing glucose and lactate levels in blood.
    Device Description
    Greiner Vacuette® blood collection tube with EDTA and sodium fluoride; and (2) its Greiner Vacuette® blood collection tube with potassium oxalate and sodium fluoride. Both Greiner Vacuette® blood collection tubes are evacuated blood collection devices intended for use in testing glucose and lactate levels in blood.
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    K Number
    K971221
    Device Name
    GREINER VACUETTE BLOOD COLLECTION TUBE
    Manufacturer
    GREINER AMERICA, INC.
    Date Cleared
    1997-05-02

    (30 days)

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

    GREINER AMERICA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Greiner Vacuette® blood collection tube with sodium citrate is an evacuated blood collection device containing sodium citrate anticoagulant additive and intended for use in evaluations of coagulation analyses.
    Device Description
    The Greiner Vacuette® blood collection tube with sodium citrate is an evacuated blood collection device containing sodium citrate anticoagulant additive. The tube material for the Greiner product is clear plastic.
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    K Number
    K960860
    Device Name
    GREINER VACUETTE BLOOD COLLECTION TUBE E/EDTA K3
    Manufacturer
    GREINER AMERICA, INC.
    Date Cleared
    1996-09-05

    (188 days)

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

    GREINER AMERICA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Greiner Vacuette™ blood collection tube with EDTA K, is an evacuated blood collection device containing EDTA K, anticoagulant additive and intended for use in evaluations of whole blood specimens.
    Device Description
    The Greiner Vacuette™ blood collection tube with EDTA K, is an evacuated blood collection device containing EDTA K, anticoagulant additive. The tube material for the Greiner product is clear plastic.
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    K Number
    K960857
    Device Name
    GREINER VACUETTE BLOOD COLLECTION TUBE W/LITHIUM HEPARIN & GEL SEPARATOR
    Manufacturer
    GREINER AMERICA, INC.
    Date Cleared
    1996-08-30

    (182 days)

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

    GREINER AMERICA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Greiner Vacuette™ blood collection tube with lithium heparin and gel separator is an evacuated blood collection device containing lithium heparin, an anticoagulant additive, and an inert polymeric barrier material. The product is intended for use in holding and separating blood plasma from the cellular components of blood.
    Device Description
    The Greiner Vacuette™ blood collection tube with lithium heparin and gel separator is an evacuated blood collection device containing lithium heparin, an anticoagulant additive, and an inert polymeric barrier material.
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    K Number
    K960858
    Device Name
    GREINER VACUTTE BLOOD COLLECTION TUBE W/ CLOT ACTIVATOR & GEL SEPARATOR
    Manufacturer
    GREINER AMERICA, INC.
    Date Cleared
    1996-08-30

    (182 days)

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

    GREINER AMERICA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Greiner Vacuette™ blood collection tube with clot activator and gel separator is an evacuated blood collection device containing a clot activator (silicondioxide) and an inert polymeric barrier material. The product is intended for use in holding and separating blood serum from the cellular components of blood.
    Device Description
    The Greiner Vacuette™ blood collection tube with clot activator and gel separator is an evacuated blood collection device containing a clot activator (silicondioxide) and an inert polymeric barrier material.
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