LogoFDA 510(k) Search
Search Filters

Search Results

Found 10 results

510(k) Data Aggregation

    K Number
    K062229
    Device Name
    CTC WORKSTATION, MODEL 2200
    Manufacturer
    MEDICAL DIAGNOSTIC TECHNOLOGIES, INC.
    Date Cleared
    2006-09-11

    (40 days)

    Product Code
    LLZ
    Regulation Number
    892.2050
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDICAL DIAGNOSTIC TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CTC Workstation system is intended for use by a qualified physician to direct the storage, display, enhancement, and viewing of ultrasound images.
    Device Description
    Under the direction of the physician the device stores, displays, and enhances ultrasound images. The image enhancement is performed by assigning pixels numeric values. The system is comprised of a software package running on off-the-shelf hardware.
    Ask a Question
    K Number
    K972209
    Device Name
    SPECTROLYSE HEPARIN (ANTI-IIA)
    Manufacturer
    MEDICAL DIAGNOSTIC TECHNOLOGIES, INC.
    Date Cleared
    1997-08-12

    (62 days)

    Product Code
    KFF
    Regulation Number
    864.7525
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDICAL DIAGNOSTIC TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Spectrolyse® Heparin (anti-IIa) is intended for the quantitative determination of therapeutic heparin (standard and low molecular weight) in human plasma by anti-fl activity.
    Device Description
    Not Found
    Ask a Question
    K Number
    K963106
    Device Name
    CHROMOLIZE PAI-1 KIT
    Manufacturer
    MEDICAL DIAGNOSTIC TECHNOLOGIES, INC.
    Date Cleared
    1996-11-18

    (98 days)

    Product Code
    GGP
    Regulation Number
    864.7290
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDICAL DIAGNOSTIC TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K960871
    Device Name
    SPECTROLYSE ANTITHROMBIN III (ANTI-XA)
    Manufacturer
    MEDICAL DIAGNOSTIC TECHNOLOGIES, INC.
    Date Cleared
    1996-08-14

    (163 days)

    Product Code
    JBQ
    Regulation Number
    864.7060
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDICAL DIAGNOSTIC TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K962489
    Device Name
    CHROMOLIZE TPA ASSAY KIT
    Manufacturer
    MEDICAL DIAGNOSTIC TECHNOLOGIES, INC.
    Date Cleared
    1996-07-31

    (35 days)

    Product Code
    GGP
    Regulation Number
    864.7290
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDICAL DIAGNOSTIC TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K960438
    Device Name
    TINTELIZE PAI-1 KIT
    Manufacturer
    MEDICAL DIAGNOSTIC TECHNOLOGIES, INC.
    Date Cleared
    1996-06-05

    (126 days)

    Product Code
    GGP
    Regulation Number
    864.7290
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDICAL DIAGNOSTIC TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K961724
    Device Name
    U-DOA CONTROLS
    Manufacturer
    MEDICAL DIAGNOSTIC TECHNOLOGIES, INC.
    Date Cleared
    1996-06-03

    (31 days)

    Product Code
    DIF
    Regulation Number
    862.3280
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDICAL DIAGNOSTIC TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K961370
    Device Name
    LA POSITIVE CONTROL PLASMA
    Manufacturer
    MEDICAL DIAGNOSTIC TECHNOLOGIES, INC.
    Date Cleared
    1996-05-24

    (45 days)

    Product Code
    GGC
    Regulation Number
    864.5425
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDICAL DIAGNOSTIC TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K955115
    Device Name
    VENOM TIEM REAGENT
    Manufacturer
    MEDICAL DIAGNOSTIC TECHNOLOGIES, INC.
    Date Cleared
    1996-04-03

    (146 days)

    Product Code
    JCO
    Regulation Number
    864.8100
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDICAL DIAGNOSTIC TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K955738
    Device Name
    BIOCLOT PROTEIN S
    Manufacturer
    MEDICAL DIAGNOSTIC TECHNOLOGIES, INC.
    Date Cleared
    1996-02-29

    (76 days)

    Product Code
    GGP
    Regulation Number
    864.7290
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDICAL DIAGNOSTIC TECHNOLOGIES, INC.

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

    Page 1 of 1