LogoFDA 510(k) Search
Search Filters

Search Results

Found 19 results

510(k) Data Aggregation

    K Number
    K011920
    Device Name
    EMIT 2000 DIGOXIN ASSAY, MODEL OSR4H229
    Manufacturer
    SYVA CO., DADE BEHRING, INC.
    Date Cleared
    2001-07-02

    (12 days)

    Product Code
    KXT
    Regulation Number
    862.3320
    Why did this record match?
    Applicant Name (Manufacturer) :

    SYVA CO., DADE BEHRING, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Emit® 2000 Digoxin Assay is a homogeneous enzyme immunoassay intended for use in the quantitative analysis of digoxin in human serum or plasma. Measurements obtained from this device are used in the diagnosis and treatment of digoxin overdose or in monitoring levels of digoxin to ensure appropriate therapy. These reagents are packaged specifically for use on a variety of OLYMPUS® analyzers.
    Device Description
    The modified assay is similar to the predicate device with minor differences in the packaging of the product. The modified assay has a smaller fill volume of the reagents into different shaped (wedge) reagent bottles. Both the predicate and modified device reagent bottles are made of the same material (HDPE). The modified reagent bottles incorporate a barcode label with assay specific information and are compatible with the OLYMPUS® AU400/600™, AU800/1000™ and AU2700™ Series Analyzers.
    Ask a Question
    K Number
    K011620
    Device Name
    EMIT 2000 N-ACETYLPROCAINAMIDE ASSAY, MODEL OSR4N229
    Manufacturer
    SYVA CO., DADE BEHRING, INC.
    Date Cleared
    2001-06-18

    (24 days)

    Product Code
    LAN
    Regulation Number
    862.3320
    Why did this record match?
    Applicant Name (Manufacturer) :

    SYVA CO., DADE BEHRING, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Emit® 2000 N-Acetylprocainamide Assay is a homogeneous enzyme immunoassay intended for use in the quantitative analysis of N-Acetylprocainamide in human serum or plasma. Measurements obtained from this device are used in the diagnosis and treatment of N-Acetylprocainamide overdose or in monitoring levels of N-Acetylprocainamide to ensure appropriate therapy. These reagents are packaged specifically for use on a variety of OLYMPUS® analyzers.
    Device Description
    The modified assay is similar to the predicate device with minor differences in the packaging of the product. The modified assay has a smaller fill volume of the reagents into different shaped (wedge) reagent bottles. Both the predicate and modified device reagent bottles are made of the same material (HDPE). The modified reagent bottles incorporate a barcode label with assay specific information and are compatible with the OLYMPUS® AU400/600™, AU800/1000™ and AU2700™ Series Analyzers.
    Ask a Question
    K Number
    K011605
    Device Name
    EMIT 2000 QUINIDINE ASSAY, MODEL OSR4Q229
    Manufacturer
    SYVA CO., DADE BEHRING, INC.
    Date Cleared
    2001-06-12

    (19 days)

    Product Code
    LBZ
    Regulation Number
    862.3320
    Why did this record match?
    Applicant Name (Manufacturer) :

    SYVA CO., DADE BEHRING, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Emit® 2000 Quinidine Assay is a homogeneous enzyme immunoassay intended for use in the quantitative analysis of quinidine in human serum or plasma. Measurements obtained from this device are used in the diagnosis and treatment of quinidine overdose or in monitoring levels of quinidine to ensure appropriate therapy. These reagents are packaged specifically for use on a variety of OLYMPUS® analyzers.
    Device Description
    The modified assay is similar to the predicate device with minor differences in the packaging of the product. The modified assay has a smaller fill volume of the reagents into different shaped (wedge) reagent bottles, Both the predicate and modified device reagent bottles are made of the same material (HDPE). The modified reagent bottles incorporate a barcode label with assay specific information and are compatible with the OLYMPUS® AU400/600™, AU800/1000™ and AU2700™ Series Analyzers.
    Ask a Question
    K Number
    K011300
    Device Name
    EMIT II PLUS CANNABINOID ASSAY, MODEL OSR9N229
    Manufacturer
    SYVA CO., DADE BEHRING, INC.
    Date Cleared
    2001-05-17

    (17 days)

    Product Code
    LDJ
    Regulation Number
    862.3870
    Why did this record match?
    Applicant Name (Manufacturer) :

    SYVA CO., DADE BEHRING, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K011306
    Device Name
    EMIT II PLUS BENZODIAZEPINE ASSAY, MODEL 0SR9F229
    Manufacturer
    SYVA CO., DADE BEHRING, INC.
    Date Cleared
    2001-05-16

    (16 days)

    Product Code
    JXM
    Regulation Number
    862.3170
    Why did this record match?
    Applicant Name (Manufacturer) :

    SYVA CO., DADE BEHRING, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K011161
    Device Name
    MODIFICATION TO THE EMIT II PLUS PHENCYCLIDINE ASSAY, MODEL OSR9J229
    Manufacturer
    SYVA CO., DADE BEHRING, INC.
    Date Cleared
    2001-05-15

    (29 days)

    Product Code
    LCM
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    SYVA CO., DADE BEHRING, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K011289
    Device Name
    EMIT II PLUS OPIATE ASSAY, MODEL OSR9B229
    Manufacturer
    SYVA CO., DADE BEHRING, INC.
    Date Cleared
    2001-05-15

    (18 days)

    Product Code
    DJG
    Regulation Number
    862.3650
    Why did this record match?
    Applicant Name (Manufacturer) :

    SYVA CO., DADE BEHRING, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K011163
    Device Name
    MODIFICATION TO THE EMIT II PLUS PROPOXYPHENE ASSAY, MODEL OSR9G229
    Manufacturer
    SYVA CO., DADE BEHRING, INC.
    Date Cleared
    2001-05-10

    (24 days)

    Product Code
    JXN
    Regulation Number
    862.3700
    Why did this record match?
    Applicant Name (Manufacturer) :

    SYVA CO., DADE BEHRING, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K011164
    Device Name
    MODIFICATION TO THE EMIT II PLUS METHAQUALONE ASSAY, MODEL OSR9Q229
    Manufacturer
    SYVA CO., DADE BEHRING, INC.
    Date Cleared
    2001-05-10

    (24 days)

    Product Code
    KXS
    Regulation Number
    862.3630
    Why did this record match?
    Applicant Name (Manufacturer) :

    SYVA CO., DADE BEHRING, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K011166
    Device Name
    MODIFICATION TO EMIT 2000 THEOPHYLLINE ASSAY, MODEL OSR 4P229
    Manufacturer
    SYVA CO., DADE BEHRING, INC.
    Date Cleared
    2001-05-10

    (24 days)

    Product Code
    KLS
    Regulation Number
    862.3880
    Why did this record match?
    Applicant Name (Manufacturer) :

    SYVA CO., DADE BEHRING, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question

    Page 1 of 2