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510(k) Data Aggregation

    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
    Type
    Traditional
    Panel
    Hematology
    Reference & Predicate Devices
    N/A
    Predicate For
    K013637
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    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

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for a device called "Spectrolyse® Heparin (anti-IIa)". It is a regulatory approval document and does not contain the acceptance criteria or study details requested in the prompt. The letter only states that the device is substantially equivalent to legally marketed predicate devices and outlines the general regulatory requirements.

    Therefore, I cannot provide the requested information based on the provided text.

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