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    K Number
    K972831
    Device Name
    HEMOCHRON CITRATE APTT
    Manufacturer
    INTERNATIONAL TECHNIDYNE CORP.
    Date Cleared
    1997-11-20

    (113 days)

    Product Code
    GFO,JPA
    Regulation Number
    864.7925
    Type
    Traditional
    Panel
    Hematology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    HEMOCHRON CITRATE APTT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The HEMOCHRON® Jr. Citrate APTT is a unitized microcoagulation test intended for in vitro diagnostic use in performing a quantitative, one-stage Activated Partial Thromboplastin Time (APTT). The APTT test is used for monitoring of low dose heparin anticoagulation (up to 1.5 units/ml). The test is performed using a citrated whole blood sample on the HEMOCHRON® Jr. microcoagulation instrument. The instrument is portable and is intended for point-of-care testing. The HEMOCHRON® Jr. is not intended for home use.

    Device Description

    Not Found

    AI/ML Overview

    This letter is an FDA clearance letter from 1997 for the Hemochron Citrate APTT, an in-vitro diagnostic device. It does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment.

    Therefore, I cannot fulfill your request for that information based solely on the provided text. The document only confirms the device's substantial equivalence to a predicate device and its intended use.

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