Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K014028
    Device Name
    CARESIDE APTT
    Manufacturer
    CARESIDE HEMOTOLOGY, INC.
    Date Cleared
    2002-02-08

    (64 days)

    Product Code
    GFO, 81G
    Regulation Number
    864.7925
    Why did this record match?
    Applicant Name (Manufacturer) :

    CARESIDE HEMOTOLOGY, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For in vitro diagnostic use with the CARESIDE Analyzer to measure activated partial thromboplastin time from citrated whole blood or citrated plasma as an aid in the diagnosis of patients with clotting disorders and to monitor patients receiving heparin anticoagulation therapy.
    Device Description
    CARESIDE APTT cartridges are used with the CARESIDE Analyzer to measure activated partial thromboplastin time from citrated whole blood or plasma as the applied sample. The CARESIDE APTT cartridge, a single use disposable in vitro diagnostic test cartridge, aids in specimen separation and delivers a measured volume of plasma to a cartridge cuvette to initiate the measurement of an activated partial thromboplastin time. The patented cartridge contains all reagents necessary to measure an activated partial thromboplastin time.
    Ask a Question

    Page 1 of 1